MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study
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. 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.
Timeline
- Start
- 2006-06
- Primary completion
- 2008-11
- Completion
- 2008-11
Outcome
Met primary endpoint
Stopped (Enrollment): “due to recruitment problems / based on recommendation of Independent Review Board”
paper The study met its primary objective to demonstrate the superiority of CE over placebo in the treatment of muscle stiffness in MS. PMID 22791906 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | standardized cannabis extract | Unknown | 25 mg | Oral |
Indications
No indication recorded.