Muscle SpasticityPhase 3MUSECNCT00552604
MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study
A Phase 3 study testing standardized cannabis extract in people with Muscle Spasticity, run by Institut fur Klinische Forschung, Germany at 1 site in United Kingdom.
Trial summary
Study Objectives: To determine the efficacy and safety of a standardised extract of Cannabis sativa given orally 2 times daily as compared to placebo for the relief of muscle stiffness and pain in multiple sclerosis for a period of 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Muscle Spasticity
- What is being tested?
- standardized cannabis extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2006to Nov 2008
- Phase
- Phase 3
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent.
- Diagnosis of MS according to McDonald criteria.
- Current muscle stiffness ≥ 4 on a 11-point categorical rating scale.
- On-going troublesome muscle stiffness for at least 3 months.
- Stable disease for the previous 6 months.
- Antispasticity medication and physiotherapy stabilised for the last 30 days.
- Patients may be ambulatory or not.
- Age 18-64.
Who cannot join
- Immunosuppressants which may affect spasticity (including corticosteroids and interferon but ex-cluding azathioprine) taken currently or in previous 30 days
- Past or present history of psychotic illness.
- Open/infected pressure sores or other source of chronic infection.
- Significant fixed tendon contractures.
- Severe cognitive impairment such that the patient is unable to provide informed consent.
- History of clinically important renal, cardiovascular or neurol. diseases (apart from MS).
Show all 17Show fewer
- Malignancy within the past 2 years.
- Cannabinoids taken currently or in previous 30 days.
- Positive qualitative urinary test on cannabinoids at screening visit. (In this case a patient will be allowed to repeat the test at a second screening visit later.)
- Known hypersensitivity to cannabinoids.
- Current drug abuse, including alcohol abuse.
- Laboratory parameters outside the following limits:
- Creatinine > 3x upper limit of normal Bilirubine > 3x upper limit of normal Transaminases > 5 x upper limit of normal
- Anticipated immunisations within the 12 weeks of trial participation.
- Other problems likely to make participation difficult at the discretion of the neurologist.
- Women who are pregnant, lactating or not using adequate contraception.
- Participation in other treatment studies currently or within the previous month.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Peninsula Medical School
Plymouth, Plymouth, PL6 8BX
About this study
Official title: Randomised, Double-blind, Placebo-controlled Phase III Trial to Determine the Efficacy and Safety of a Standardised Oral Extract of Cannabis Sativa for the Symptomatic Relief of Muscle Stiffness and Pain in Multiple Sclerosis.
Study Objectives: To determine the efficacy and safety of a standardised extract of Cannabis sativa given orally 2 times daily as compared to placebo for the relief of muscle stiffness and pain in multiple sclerosis for a period of 12 weeks.
Study Patients: 400 patients with multiple sclerosis (age 18-64, stable disease during previous 6 months, ambulatory or not, antispasticity medication and physiotherapy stabilised ≥ 30 days) with experiencing muscle stiffness ≥ 4 on a 11-point numerical Likert scale at baseline.
Read more
Study treatment:
Group 1: Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily, additionally to previous antispasticity and analgesic medication.
Group 2: Matched placebo, twice daily, additionally to previous antispasticity and analgesic medication.
Treatment Schedule: Start dose 5 mg THC/d, individual dose titration with increase of 5 mg THC every 3 days, maximal total daily dose 25 mg THC, administered as 2 equal doses based on tolerability. Treatment duration: 12 weeks.
Study sites: 20 neurological clinics in the United Kingdom.
- Conditions
- Muscle Spasticity
- Being tested
- standardized cannabis extract, Placebo
- Keywords
- multiple sclerosis, muscle stiffness, spasticity, pain, treatment, cannabinoids
- Medical subject headings
- Muscle Spasticity, Multiple Sclerosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized cannabis extractDrug
Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily
PlaceboDrug
Matching placebo capsules, twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily Receives: Drug: standardized cannabis extract |
| 2 | Placebo comparator | matching placebo capsules, twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle stiffness: 11-point numerical Likert scale
Measured: 12 weeks
Secondary outcomes (1)
Change in pain: 11-point numerical Likert scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startJun 2006
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: due to recruitment problems / based on recommendation of Independent Review Board
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle SpasticityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut fur Klinische Forschung, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Weleda AG
- Responsible party
- Sponsor
- Investigators
- John J Zajicek, Prof., Principal investigator, Peninsula Medical School, University of Plymouth, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552604
- Sponsor's protocol ID
- 25-01
- Other IDs
- EUDRA-CT No., 2005-005263-29, 2005
- Acronym
- MUSEC
- Status last verified
- Mar 2015
- First submitted
- 1 Nov 2007
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zajicek JP, Hobart JC, Slade A, Barnes D, Mattison PG; MUSEC Research Group. Multiple sclerosis and extract of cannabis: results of the MUSEC trial. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1125-32. doi: 10.1136/jnnp-2012-302468. Epub 2012 Jul 12.
PubMed 22791906
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled Phase III Trial to Determine the Efficacy and Safety of a Standardised Oral Extract of Cannabis Sativa for the Symptomatic Relief of Muscle Stiffness and Pain in Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT00552604
- Acronym / sponsor ID
- MUSEC / 25-01
- Conditions
- Muscle Spasticity
- Keywords
- multiple sclerosis, muscle stiffness, spasticity, pain, treatment, cannabinoids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to recruitment problems / based on recommendation of Independent Review Board
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Institut fur Klinische Forschung, GermanyUniversity, hospital or other
- Collaborators
- Weleda AG
- Study start
- Jun 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 2 Nov 2007 (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.
Study Objectives: To determine the efficacy and safety of a standardised extract of Cannabis sativa given orally 2 times daily as compared to placebo for the relief of muscle stiffness and pain in multiple sclerosis for a period of 12 weeks.
Study Patients: 400 patients with multiple sclerosis (age 18-64, stable disease during previous 6 months, ambulatory or not, antispasticity medication and physiotherapy stabilised ≥ 30 days) with experiencing muscle stiffness ≥ 4 on a 11-point numerical Likert scale at baseline.
Study treatment:
Group 1: Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily, additionally to previous antispasticity and analgesic medication.
Group 2: Matched placebo, twice daily, additionally to previous antispasticity and analgesic medication.
Treatment Schedule: Start dose 5 mg THC/d, individual dose titration with increase of 5 mg THC every 3 days, maximal total daily dose 25 mg THC, administered as 2 equal doses based on tolerability. Treatment duration: 12 weeks.
Study sites: 20 neurological clinics in the United Kingdom.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: standardized cannabis extractCannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily |
| 2 | Placebo comparator | Drug: Placebomatching placebo capsules, twice daily |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed informed consent.
- Diagnosis of MS according to McDonald criteria.
- Current muscle stiffness ≥ 4 on a 11-point categorical rating scale.
- On-going troublesome muscle stiffness for at least 3 months.
- Stable disease for the previous 6 months.
Key exclusion criteria (17 listed)
- Immunosuppressants which may affect spasticity (including corticosteroids and interferon but ex-cluding azathioprine) taken currently or in previous 30 days
- Past or present history of psychotic illness.
- Open/infected pressure sores or other source of chronic infection.
- Significant fixed tendon contractures.
- Severe cognitive impairment such that the patient is unable to provide informed consent.
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 |
|---|---|---|
| standardized cannabis extractCannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily | Drug | 1 |
| PlaceboMatching placebo capsules, twice daily | Drug | 2 |
Primary outcome
Change in muscle stiffness: 11-point numerical Likert scale
Time frame: 12 weeks
1 secondary outcome
Change in pain: 11-point numerical Likert scale
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: due to recruitment problems / based on recommendation of Independent Review Board). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Derived from this study: PubMed 22791906Zajicek JP, Hobart JC, Slade A, Barnes D, Mattison PG; MUSEC Research Group. Multiple sclerosis and extract of cannabis: results of the MUSEC trial. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1125-32. doi: 10.1136/jnnp-2012-302468. Epub 2012 Jul 12.
Related trials for Muscle Spasticity
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
Spinal Cord Injury, Spasticity
Not yet recruiting
Evaluating the Effects of the EXOPULSE Suit on Mobility, Walking Ability, and Balance in People With Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Multiple Sclerosis Spasticity
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.
John J Zajicek, Prof. principal investigator
Peninsula Medical School, University of Plymouth, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing standardized cannabis extract in people with Muscle Spasticity, run by Institut fur Klinische Forschung, Germany at 1 site in United Kingdom.
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 8 inclusion and 17 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 25 Mar 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 United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: due to recruitment problems / based on recommendation of Independent Review Board). Results are not available in the source record.
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 in muscle stiffness: 11-point numerical Likert scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00552604, which also lists 1 linked publication.
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 Mar 2015.