MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study
- Conditions
- Muscle Spasticity
- Interventions
- Drug: Placebo
- Registration Number
- NCT00552604
- Lead Sponsor
- Institut fur Klinische Forschung, Germany
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 279
- 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.
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo matching placebo capsules, twice daily 1 standardized cannabis extract 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
- Primary Outcome Measures
Name Time Method Change in muscle stiffness: 11-point numerical Likert scale 12 weeks
- Secondary Outcome Measures
Name Time Method Change in pain: 11-point numerical Likert scale 12 weeks
Trial Locations
- Locations (1)
Peninsula Medical School
🇬🇧Plymouth, United Kingdom