MUltiple Sclerosis and Extract of Cannabis (MUSEC): a 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 (MS)
- Conditions
- Multiple sclerosisNervous System Diseases
- Registration Number
- ISRCTN42223114
- Lead Sponsor
- Institute for Clinical Research (Institut fur klinische Forschung) (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 400
1. Diagnosis of MS according to McDonald criteria
2. Current muscle stiffness greater than or equal to 4 on a 11-point categorical rating scale
3. On-going troublesome muscle stiffness for at least 3 months before enrolling in the trial
4. Stable disease for the previous 6 months in the opinion of the treating physician
5. Antispasticity medication and physiotherapy stabilised for the last 30 days
6. Patients may be ambulatory or not
7. Age 18 - 64 years
1. Immunosuppressants which may affect spasticity (including corticosteroids and interferon but excluding azathioprine) taken currently or in previous 30 days
2. Open/infected pressure sores or other source of chronic infection
3. Significant fixed tendon contractures
4. Cannabinoids taken currently or in previous 30 days
5. Positive qualitative urinary test on cannabinoids at screening visit
6. Laboratory parameters outside the following limits:
6.1. Creatinine greater than 3 x upper limit of normal
6.2. Bilirubin greater than 3 x upper limit of normal
6.3. Transaminases greater than 5 x upper limit of normal
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method