Multiple SclerosisPhase 1/2NCT00682929
Cannabis for Spasticity in Multiple Sclerosis
A Phase 1/2 study testing Inhaled Cannabis and Oral THC in people with Multiple Sclerosis, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Inhaled Cannabis and Oral THC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2004to 17 Aug 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria
- Moderate or severe spasticity
- Age 21 or older
- Must live close to the Sacramento, CA area
Who cannot join
- Preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders
- Preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders
- Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study
- Pre-existing dementia, mania, depression or schizophrenia or other poorly controlled psychiatric illness
- Past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months
- History of or currently meets DSM-IV criteria for dependence on cannabis
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- Use of cannabis, marijuana, or THC in the last four weeks
- Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness
- Exacerbation of MS within 30 days prior to screening visit
- Current use of cyclophosphamide, mitoxantrone, or cladribine
- Arthritis, bony and soft tissue disorders interfering with spasticity measures
- Inability to provide informed consent
- Recent cannabis use of more than twice per week one month prior to study entry
- For females of child bearing potential, inability to comply with adequate contraception
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study
The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.
Read the detailed description
The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks. Immunomodulatory agents, available in this disease over the last decade, reduce the frequency of severe attacks by about one third. The remainder of the treatments are symptomatic, aimed at reducing the disability already present.
Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS. In light of the autoimmune hypothesis of the etiology of MS, THC could directly alter immune function in a manner that might reduce (or increase) the primary pathology of the disease.
Comparisons: Three treatment arms will be compared:
- inhaled cannabis and oral placebo
- inhaled placebo and oral THC
- inhaled placebo and oral placebo
The effects of these agents analyzed at 3 weeks and 7 weeks.
- Conditions
- Multiple Sclerosis
- Being tested
- Inhaled Cannabis, Oral THC, Oral Placebo, Inhaled placebo
- Keywords
- cannabis, marijuana, Multiple Sclerosis, spasticity
- Medical subject headings
- Multiple Sclerosis, Marijuana Abuse, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled CannabisDrug
Also called Cannabis
Participants will be instructed to smoke one cannabis cigarette, daily for 7 weeks.
Oral THCDrug
Also called dronabinol
Participants will be instructed to take two 5 mg dronabinol tablets two hours prior to the inhaled medication, daily for 7 weeks.
Oral PlaceboDrug
Also called placebo
Participants will be instructed to take two placebo tablets two hours prior to the inhaled medication, daily for 7 weeks.
Inhaled placeboDrug
Also called placebo
Participants will be instructed to smoke one placebo cigarette, daily for 7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1) Inhaled Cannabis | Active comparator | Inhaled cannabis is compared to oral placebo. Receives: Drug: Inhaled Cannabis; Drug: Oral Placebo |
| 2) Oral THC | Active comparator | Inhaled placebo is compared to oral THC. Receives: Drug: Oral THC; Drug: Inhaled placebo |
| 3) Placebo | Placebo comparator | Inhaled placebo is compared to oral placebo. Receives: Drug: Oral Placebo; Drug: Inhaled placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Week 0 to Week 3 in the Rate of Torque Increase, Flexion
A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 3 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 3 in the Rate of Torque Increase, Extension
A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 3 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in the Rate of Torque Increase, Flexion
A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 7 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.
Measured: Week 0, Week 7
LIDO Machine Score - Rate of Torque Increase, Extension
A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 7 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.
Measured: Week 0, Week 7
Secondary outcomes (50)
Change From Week 0 to Week 3 in Modified Ashworth Score (MAS)
The Modified Ashworth scale measures resistance during passive soft-tissue stretching. Spasticity is graded on a scale of 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). The highest score (flexion or extension), for the lower extremities only, was used for each subject. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in spasticity and correlates to a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in Modified Ashworth Score
The Modified Ashworth scale measures resistance during passive soft-tissue stretching. Spasticity is graded on a scale of 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). The highest score (flexion or extension), for the lower extremities only, was used for each subject. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in spasticity and correlates to a better outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in Ambulation Index (AI) Score
The AI is a 9-point rating scale used to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic, fully active) to 9 (restricted to wheelchair, unable to transfer self independently). Lower scores represent a better outcome for MS patients. For this study, the AI score was based on the results of the 25 Foot Walk test, also performed at the study visit. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result for this outcome indicates an improvement in ambulation and correlates to a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in Ambulation Index (AI) Score
The AI is a 9-point rating scale used to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic, fully active) to 9 (restricted to wheelchair, unable to transfer self independently). Lower scores represent a better outcome for MS patients. For this study, the AI score was based on the results of the 25 Foot Walk test, also performed at the study visit. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result for this outcome indicates an improvement in ambulation and correlates to a better outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in 25 Foot Walk Time
The Timed 25 Foot Walk is a quantitative measure of lower extremity function. The patient is instructed to walk on a marked 25-foot course, as quickly and as safely as possible. The patient is allowed to use his/her typical walking aid, if applicable. The task is completed twice and the average time of the two trials was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time. A negative result indicates an improvement in walking ability and correlates to a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in 25 Foot Walk Time
The Timed 25 Foot Walk is a quantitative measure of lower extremity function. The patient is instructed to walk on a marked 25-foot course, as quickly and as safely as possible. The patient is allowed to use his/her typical walking aid, if applicable. The task is completed twice and the average time of the two trials was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time. A negative result indicates an improvement in walking ability and correlates to a better outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in 9 Hole Peg Test (Dominant Hand) Time
The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time.
A negative result indicates an improvement in arm and hand function and correlates with a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in 9 Hole Peg Test (Dominant Hand) Time
The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time.
A negative result indicates an improvement in arm and hand function and correlates with a better outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in 9 Hole Peg Test (Non- Dominant Hand) Time
The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The non-dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time.
A negative result indicates an improvement in arm and hand function and correlates with a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in 9 Hole Peg Test (Non- Dominant Hand) Time
The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time.
A negative result indicates an improvement in arm and hand function and correlates with a better outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in Paced Auditory Serial Addition Test (PASAT) Score
The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability; The test is presented via recording on a CD to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test score is the number of correct sums given (out of a possible 60) in each trial. There are 2 test forms, A and B. The forms were alternated and at least 1 practice test (10 sums) was performed prior to each trial. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in performance and correlates with a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in Paced Auditory Serial Addition Test (PASAT) Score
The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability; The test is presented via recording on a CD to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test score is the number of correct sums given (out of a possible 60) in each trial. There are 2 test forms, A and B. The forms were alternated and at least 1 practice test (10 sums) was performed prior to each trial. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in performance and correlates with a better outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Vision
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Vision score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (grade 5 plus maximal visual acuity of better eye of 20/60 (0.3) or less).
Higher values indicate more impaired vision. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in vision and correlates to a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Vision
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Vision score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (grade 5 plus maximal visual acuity of better eye of 20/60 (0.3) or less).
Higher values indicate more impaired vision. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in vision and correlates to a better outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Brainstem
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Brainstem score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (inability to swallow or speak). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Brainstem
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Brainstem score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (inability to swallow or speak). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Pyramidal
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Pyramidal score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (tetraplegia (grade 0 or 1 in all muscle groups of upper and lower limbs). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Pyramidal
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Pyramidal score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (tetraplegia (grade 0 or 1 in all muscle groups of upper and lower limbs). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Cerebellar
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebellar score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (unable to perform coordinated movements due to ataxia). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Cerebellar
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebellar score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (unable to perform coordinated movements due to ataxia). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Sensory
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Sensory score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (sensation essentially lost below the head). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Sensory
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Sensory score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (sensation essentially lost below the head). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Bowel and Bladder
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Bowel and Bladder score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (loss of bowel and bladder function). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Bowel and Bladder
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Bowel and Bladder score is determined by a 7-point scale, with 0 being the lowest (normal) and 6 being the highest (loss of bowel and bladder function). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Cerebral
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebral score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (dementia). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome. Fatigue did not contribute to this FS score or the EDSS total score.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Cerebral
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The FS Cerebral score is determined by a 6-point scale, with 0 being the lowest (normal) and 5 being the highest (dementia). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome. Fatigue did not contribute to this FS score or the EDSS total score.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in Expanded Disability Status Score (EDSS)
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The total EDSS score ranges from 0 to 10, in 0.5 unit increments. A score of 0 is the lowest (normal neurological exam) and 10 is the highest (death due to MS). Higher values indicate more impaired function. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in Expanded Disability Status Score (EDSS)
The EDSS is a method of quantifying disability in MS patients and monitoring changes in the level of disability over time. The EDSS quantifies disability in 7 functional systems (FS): visual, brainstem, pyramidal, cerebellar, sensory, bowel and bladder, and cerebral, and includes a measure of ambulation. Neurostatus version 10/2002 was used for this study. The total EDSS score ranges from 0 to 10, in 0.5 unit increments. A score of 0 is the lowest (normal neurological exam) and 10 is the highest (death due to MS). Higher values indicate more impaired function. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in function and correlates to a better outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score
The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A positive result indicates an improvement in health status and correlates to a better outcome. A negative result indicates a decline in health and correlates to a worse outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score
The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A positive result indicates an improvement in health status and correlates to a better outcome. A negative result indicates a decline in health and correlates to a worse outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component Score
The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 3 score and subtracting the Week 0. A positive result indicates an improvement in mental health status and correlates to a better outcome. A negative result indicates a decline in mental health and correlates to a worse outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component
The SF-36 is a 36-item scale developed as a generic health status measure. It is a part of the MS Quality of Life Inventory. It can be reported as 2 summary scales - the Physical and Mental components. The scale is measured from 0 -100. The scale is set up so that a higher score indicates better health. The change was calculated by taking the Week 3 score and subtracting the Week 0. A positive result indicates an improvement in mental health status and correlates to a better outcome. A negative result indicates a decline in mental health and correlates to a worse outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week3 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score
The Modified Fatigue Index is a 21-item scale developed to assess the perceived impact of fatigue on daily activities. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-84. The scale is set up so that a higher score indicates a greater impact of fatigue on a patient's daily activities. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of fatigue on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of fatigue on daily activities and correlates to a worse outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score
The Modified Fatigue Index is a 21-item scale developed to assess the perceived impact of fatigue on daily activities. It is a part of the MS Quality of Life Inventory. The scale is measured from 0 - 84. The scale is set up so that a higher score indicates a greater impact of fatigue on a patient's daily activities. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of fatigue on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of fatigue on daily activities and correlates to a worse outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score
The Pain Effects Scale is a 6-item scale developed to assess the effects of pain on behavior and mood. It is a part of the MS Quality of Life Inventory. The scale is measured from 6-30. The scale is set up so that a higher score indicates a greater impact of pain on a patient's mood and behavior. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of pain on mood and behavior and correlates to a better outcome. A positive result indicates an increase in the impact of pain on mood and behavior and correlates to a worse outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score
The Pain Effects Scale is a 6-item scale developed to assess the effects of pain on behavior and mood. It is a part of the MS Quality of Life Inventory. The scale is measured from 6-30. The scale is set up so that a higher score indicates a greater impact of pain on a patient's mood and behavior. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of pain on mood and behavior and correlates to a better outcome. A positive result indicates an increase in the impact of pain on mood and behavior and correlates to a worse outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score
The Sexual Satisfaction Scale is a 4-item scale developed to assess the impact of multiple sclerosis on sexual function and satisfaction. It is a part of the MS Quality of Life Inventory. The scale is measured from 4-24. The scale is set up so that a higher score indicates greater problems with sexual satisfaction. Subjects that answered "No" to the question, "Do you have a relationship with one primary partner", did not complete the scale. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in sexual satisfaction and correlates to a better outcome. A positive result indicates a decrease in sexual satisfaction and correlates to a worse outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score
The Sexual Satisfaction Scale is a 4-item scale developed to assess the impact of multiple sclerosis on sexual function and satisfaction. It is a part of the MS Quality of Life Inventory. The scale is measured from 4-24. The scale is set up so that a higher score indicates greater problems with sexual satisfaction. Subjects that answered "No" to the question, "Do you have a relationship with one primary partner", did not complete the scale. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in sexual satisfaction and correlates to a better outcome. A positive result indicates a decrease in sexual satisfaction and correlates to a worse outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score
The Bladder Control Scale is a 4-item scale developed to assess the impact of multiple sclerosis on bladder function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-22. The scale is set up so that a higher score indicates greater bladder control problems. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in bladder control and correlates to a better outcome. A positive result indicates a decrease in bladder control and correlates to a worse outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score
The Bladder Control Scale is a 4-item scale developed to assess the impact of multiple sclerosis on bladder function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-22. The scale is set up so that a higher score indicates greater bladder control problems. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in bladder control and correlates to a better outcome. A positive result indicates a decrease in bladder control and correlates to a worse outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score
The Bowel Control Scale is a 5-item scale developed to assess the impact of multiple sclerosis on bowel function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-26. The scale is set up so that a higher score indicates greater bowel control problems. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates an improvement in bowel control and correlates to a better outcome. A positive result indicates a decrease in bowel control and correlates to a worse outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score
The Bowel Control Scale is a 5-item scale developed to assess the impact of multiple sclerosis on bowel function. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-26. The scale is set up so that a higher score indicates greater bowel control problems. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates an improvement in bowel control and correlates to a better outcome. A positive result indicates a decrease in bowel control and correlates to a worse outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score
The Impact of Visual Impairment Scale is a 5-item scale developed to assess the extent to which activities dependent on vision are affected by MS-related visual problems. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-15. The scale is set up so that a higher score indicates greater impact of visual problems on daily activities. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of visual problems on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of visual problems on daily activities and correlates to a worse outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score
The Impact of Visual Impairment Scale is a 5-item scale developed to assess the extent to which activities dependent on vision are affected by MS-related visual problems. It is a part of the MS Quality of Life Inventory. The scale is measured from 0-15. The scale is set up so that a higher score indicates greater impact of visual problems on daily activities. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the impact of visual problems on daily activities and correlates to a better outcome. A positive result indicates an increase in the impact of visual problems on daily activities and correlates to a worse outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score
The Perceived Deficits Scale is a 20-item scale developed to assess the patient's perceived cognitive deficits. It is composed of four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-80. The scale is set up so that a higher score indicates greater perceived cognitive impairment. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in the perception of cognitive impairment. A positive result indicates an increase in the perception of cognitive impairment. Since patient perceptions of cognitive impairment may not correlate with objective measures of cognitive impairment, the results should be interpreted with caution.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score
The Perceived Deficits Scale is a 20-item scale developed to assess the patient's perceived cognitive deficits. It is composed of four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-80. The scale is set up so that a higher score indicates greater perceived cognitive impairment. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in the perception of cognitive impairment. A positive result indicates an increase in the perception of cognitive impairment. Since patient perceptions of cognitive impairment may not correlate with objective measures of cognitive impairment, the results should be interpreted with caution.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score
The Mental Health Inventory (MHI) is an 18-item scale developed as a measure of overall emotional functioning. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates better mental health. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A positive result indicates an improvement in mental health and correlates to a better outcome. A negative result indicates decrease in mental health and correlates to a worse outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score
The Mental Health Inventory (MHI) is an 18-item scale developed as a measure of overall emotional functioning. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates better mental health. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A positive result indicates an improvement in mental health and correlates to a better outcome. A negative result indicates decrease in mental health and correlates to a worse outcome.
Measured: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score
The Modified Social Support Scale is an 18-item scale developed as a measure of perceived social support. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates greater perceived support. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A positive result indicates an improvement in perceived support and correlates to a better outcome. A negative result indicates a decrease in perceived support and correlates to a worse outcome.
Measured: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score
The Modified Social Support Scale is an 18-item scale developed as a measure of perceived social support. It is a part of the MS Quality of Life Inventory. The total score is measured from 0-100. The scale is set up so that a higher score indicates greater perceived support. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A positive result indicates an improvement in perceived support and correlates to a better outcome. A negative result indicates a decrease in perceived support and correlates to a worse outcome.
Measured: Week 0, Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study start14 Apr 2004
- Primary completion17 Aug 2011
- Study completion17 Aug 2011
Why it stopped: Unable to complete subject recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Sponsor
- Investigators
- Michelle Apperson, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682929
- Sponsor's protocol ID
- 251429
- Other IDs
- MS Society Award # RG 3781-A-1
- Status last verified
- Apr 2018
- First submitted
- 19 May 2008
- Last updated
- 18 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT00682929
- Acronym / sponsor ID
- 251429
- Conditions
- Multiple Sclerosis
- Keywords
- cannabis, marijuana, Multiple Sclerosis, spasticity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to complete subject recruitment
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 14 Apr 2004 (actual)
- Primary completion
- 17 Aug 2011 (actual)
- Study completion
- 17 Aug 2011 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Posted 18 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.
Detailed description
The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks. Immunomodulatory agents, available in this disease over the last decade, reduce the frequency of severe attacks by about one third. The remainder of the treatments are symptomatic, aimed at reducing the disability already present.
Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS. In light of the autoimmune hypothesis of the etiology of MS, THC could directly alter immune function in a manner that might reduce (or increase) the primary pathology of the disease.
Comparisons: Three treatment arms will be compared:
- inhaled cannabis and oral placebo
- inhaled placebo and oral THC
- inhaled placebo and oral placebo
The effects of these agents analyzed at 3 weeks and 7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1) Inhaled Cannabis | Active comparator | Drug: Inhaled Cannabis, Drug: Oral PlaceboInhaled cannabis is compared to oral placebo. |
| 2) Oral THC | Active comparator | Drug: Oral THC, Drug: Inhaled placeboInhaled placebo is compared to oral THC. |
| 3) Placebo | Placebo comparator | Drug: Oral Placebo, Drug: Inhaled placeboInhaled placebo is compared to oral placebo. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria
- Moderate or severe spasticity
- Age 21 or older
- Must live close to the Sacramento, CA area
Key exclusion criteria (14 listed)
- Preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders
- Preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders
- Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study
- Pre-existing dementia, mania, depression or schizophrenia or other poorly controlled psychiatric illness
- Past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled CannabisAlso: CannabisParticipants will be instructed to smoke one cannabis cigarette, daily for 7 weeks. | Drug | 1) Inhaled Cannabis |
| Oral THCAlso: dronabinolParticipants will be instructed to take two 5 mg dronabinol tablets two hours prior to the inhaled medication, daily for 7 weeks. | Drug | 2) Oral THC |
| Oral PlaceboAlso: placeboParticipants will be instructed to take two placebo tablets two hours prior to the inhaled medication, daily for 7 weeks. | Drug | 1) Inhaled Cannabis, 3) Placebo |
| Inhaled placeboAlso: placeboParticipants will be instructed to smoke one placebo cigarette, daily for 7 weeks. | Drug | 2) Oral THC, 3) Placebo |
Primary outcome
Change From Week 0 to Week 3 in the Rate of Torque Increase, Flexion
Time frame: Week 0, Week 3
A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 3 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.
Change From Week 0 to Week 3 in the Rate of Torque Increase, Extension
Time frame: Week 0, Week 3
A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 3 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.
Change From Week 0 to Week 7 in the Rate of Torque Increase, Flexion
Time frame: Week 0, Week 7
A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 7 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.
LIDO Machine Score - Rate of Torque Increase, Extension
Time frame: Week 0, Week 7
A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. The active (involuntary) resistance is the result of the stretch reflex and correlates well with the clinical assessment of spasticity. The change was calculated by taking the value at Week 7 and subtracting the value at Week 0. A negative result indicates a decrease in the torque measured and correlates to a decrease in spasticity and a better outcome.
50 secondary outcomes
Change From Week 0 to Week 3 in Modified Ashworth Score (MAS)
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in Modified Ashworth Score
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in Ambulation Index (AI) Score
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in Ambulation Index (AI) Score
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in 25 Foot Walk Time
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in 25 Foot Walk Time
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in 9 Hole Peg Test (Dominant Hand) Time
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in 9 Hole Peg Test (Dominant Hand) Time
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in 9 Hole Peg Test (Non- Dominant Hand) Time
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in 9 Hole Peg Test (Non- Dominant Hand) Time
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in Paced Auditory Serial Addition Test (PASAT) Score
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in Paced Auditory Serial Addition Test (PASAT) Score
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Vision
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Vision
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Brainstem
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Brainstem
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Pyramidal
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Pyramidal
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Cerebellar
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Cerebellar
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Sensory
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Sensory
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Bowel and Bladder
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Bowel and Bladder
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in Functional System Score - Cerebral
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in Functional System Score - Cerebral
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in Expanded Disability Status Score (EDSS)
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in Expanded Disability Status Score (EDSS)
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component Score
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component
Time frame: Week 0, Week 7
Change From Week 0 to Week3 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score
Time frame: Week 0, Week 7
Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score
Time frame: Week 0, Week 3
Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score
Time frame: Week 0, Week 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Apperson, MD, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Inhaled Cannabis and Oral THC in people with Multiple Sclerosis, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Week 0 to Week 3 in the Rate of Torque Increase, Flexion (time frame: Week 0, Week 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018; AzTrials last refreshed its copy on 29 Oct 2026.