Muscle Spasticity as a Result of Spinal Cord InjuryPhase 2NCT01222468
Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
A Phase 2 study testing nabilone 0.5 mg in people with Muscle Spasticity as a Result of Spinal Cord Injury, run by University of Manitoba at 1 site in Canada.
Trial summary
This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on spasticity in spinal cord injured persons.The study will be a phase 2, randomized, placebo-controlled crossover study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Muscle Spasticity as a Result of Spinal Cord Injury
- What is being tested?
- nabilone 0.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal Cord Injury
- 12 months post -injury
- C2-T12, ASIA A-D, stable level of injury
- moderate to severe spasticity or moderate to severe neuropathic pain
- no cognitive impairment
- spasticity medications unchanged for at least 30 days or inadequate pain control at a stabilized dose of either gabapentin or pregabalin for at least 30 days
- no botulinum toxin injections x 6 months
Who cannot join
- significant cardiovascular disease
- major illness in another body area
- history of psychological disorders or predisposition to psychosis
- sensitivity to cannabinoids
- severe liver disfunction
- history of drug dependancy
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- fixed tendon contractures
- used cannabis in the past 30 days
- unwilling to refrain from smoking cannabis during the study
- pregnant or nursing mother
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health Sciences Centre Rehabilitation Hospital
Winnipeg, Manitoba, R3A 1M4
About this study
Official title: A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on spasticity in spinal cord injured persons.The study will be a phase 2, randomized, placebo-controlled crossover study. Each eligible subject will participate for 26 weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of the study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to the opposite arm for another 11 week treatment period (phase 2).
- Being tested
- nabilone 0.5 mg, placebo
- Keywords
- Spasticity, Spinal Cord Injury
- Medical subject headings
- Muscle Spasticity, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nabilone 0.5 mgDrug
Also called Cesamet
nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase
placeboDrug
placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase
| Study group | Role | What they receive |
|---|---|---|
| nabilone | Active comparator | nabilone 0.5 mg tablets dose-titrated over an 11-week period to a maximum of 3mg po daily. Subjects are allowed to drop back to the previous dose following a dose increase once if required Receives: Drug: nabilone 0.5 mg |
| placebo | Placebo comparator | look-alike 0.5 mg placebo tablets titrated to a maximum daily dose of 3.0 mg daily over an 11-week phase. Subjects are allowed to drop back to the previous dose following a dose increase once during the 11-week phase if required Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ashworth Scale
A scale that grades resistance to rapid passive movement across a relaxed joint on an ordinal scale of 0 to 4.
Measured: 26 weeks
VAS (visual analog scale)pain intensity scale
Primary outcome measure for pain will be a change in the VAS pain intensity scale. Using a visual intensity scale, patients are asked to record their daily pain score over the previous 24 hours.
Measured: 26 weeks
Secondary outcomes (9)
Sum of the Ashworth Scale in the eight muscle groups of each side of the body.
As above
Measured: 26 weeks
Penn Spasm Frequency Scale
Scale graded by study participants to measure frequency of muscle spasms throughout the period in question
Measured: 26 weeks
Visual Analog Scale
Patients rate the intensity of their spasms on a 100 mm pencil and paper VAS scale
Measured: 26 weeks
Pittsburgh Sleep Quality Index
Questionnaire that measures patient-reported sleep quality that will be administered at Visits 1,6 and 12
Measured: 26 weeks
Subject's Global Impression of Change
Questionnaire that asks the subject to rate his or her impression of the effects of the study medication.
Measured: 26 weeks
Clinician's Global Impression of Change
Questionnaire that asks the Clinician to rate his or her impression of the effect of study medication.
Measured: 26 weeks
VAS Pain Impact Scale
A continuous scale measuring the impact of pain with 0mm being non-disruptive and 100 mm being incapacitating
Measured: 26 weeks
The Short Form McGill Pain Questionnaire (SF-MPQ)
A questionnaire with 3 components: a VAS to determine overall pain levels, a 15-word list of pain descriptors; and a Present Pain Intensity Scale to determine patient's pain at the time of survey completion
Measured: 26 weeks
Neuropathic Pain Questionnaire
A clinician-administered questionnaire consisting of both sensory descriptors and signs related to bedside sensory examination
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startJun 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Spasticity as a Result of Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- The Manitoba Spinal Cord Injury Research Fund, Canadian Paraplegic Association, Health Sciences Centre Foundation, Manitoba
- Responsible party
- Principal investigator, Dr. Karen Ethans, University of Manitoba
- Investigators
- Karen D. Ethans, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222468
- Sponsor's protocol ID
- 1976
- Status last verified
- Feb 2015
- First submitted
- 14 Oct 2010
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blinded Crossover Trial Assessing the Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons
- ClinicalTrials.gov ID
- NCT01222468
- Acronym / sponsor ID
- 1976
- Keywords
- Spasticity, Spinal Cord Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- The Manitoba Spinal Cord Injury Research Fund, Canadian Paraplegic Association, Health Sciences Centre Foundation, Manitoba
- Study start
- Jun 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on spasticity in spinal cord injured persons.The study will be a phase 2, randomized, placebo-controlled crossover study. Each eligible subject will participate for 26 weeks.Subjects will be randomized to receive either nabilone or placebo during phase 1 of the study. Study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the first 11-week phase. Following a 4-week washout period, subjects will be crossed-over to the opposite arm for another 11 week treatment period (phase 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nabilone | Active comparator | Drug: nabilone 0.5 mgnabilone 0.5 mg tablets dose-titrated over an 11-week period to a maximum of 3mg po daily. Subjects are allowed to drop back to the previous dose following a dose increase once if required |
| placebo | Placebo comparator | Drug: placebolook-alike 0.5 mg placebo tablets titrated to a maximum daily dose of 3.0 mg daily over an 11-week phase. Subjects are allowed to drop back to the previous dose following a dose increase once during the 11-week phase if required |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Spinal Cord Injury
- 12 months post -injury
- C2-T12, ASIA A-D, stable level of injury
- moderate to severe spasticity or moderate to severe neuropathic pain
- no cognitive impairment
Key exclusion criteria (10 listed)
- significant cardiovascular disease
- major illness in another body area
- history of psychological disorders or predisposition to psychosis
- sensitivity to cannabinoids
- severe liver disfunction
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 |
|---|---|---|
| nabilone 0.5 mgAlso: Cesametnabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase | Drug | nabilone |
| placeboplacebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase | Drug | placebo |
Primary outcome
Ashworth Scale
Time frame: 26 weeks
A scale that grades resistance to rapid passive movement across a relaxed joint on an ordinal scale of 0 to 4.
VAS (visual analog scale)pain intensity scale
Time frame: 26 weeks
Primary outcome measure for pain will be a change in the VAS pain intensity scale. Using a visual intensity scale, patients are asked to record their daily pain score over the previous 24 hours.
9 secondary outcomes
Sum of the Ashworth Scale in the eight muscle groups of each side of the body.
Time frame: 26 weeks
Penn Spasm Frequency Scale
Time frame: 26 weeks
Visual Analog Scale
Time frame: 26 weeks
Pittsburgh Sleep Quality Index
Time frame: 26 weeks
Subject's Global Impression of Change
Time frame: 26 weeks
Clinician's Global Impression of Change
Time frame: 26 weeks
VAS Pain Impact Scale
Time frame: 26 weeks
The Short Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 26 weeks
Neuropathic Pain Questionnaire
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
Related trials for Muscle Spasticity as a Result of Spinal Cord Injury
Recruiting
Spasticity in SCI Following Acute Intermittent Hypoxia
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Active, not recruiting
Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury
Spinal Cord Injuries
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.
Karen D. Ethans, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nabilone 0.5 mg in people with Muscle Spasticity as a Result of Spinal Cord Injury, run by University of Manitoba at 1 site in Canada.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 25 Feb 2015. 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 Canada. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ashworth Scale (time frame: 26 weeks). The study lists 2 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 25 Feb 2015.