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)
| ISRCTN | ISRCTN42223114 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42223114 |
| ClinicalTrials.gov number | NCT00552604 |
| Secondary identifying numbers | '25-01 |
- Submission date
- 10/10/2007
- Registration date
- 17/10/2007
- Last edited
- 03/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof John Zajicek
Scientific
Scientific
Peninsula Medical School
ITTC Building 1
Tamar Science Park
1 Davy Road
Plymouth
PL6 8BX
United Kingdom
| Phone | +44 (0)1752 315 250 |
|---|---|
| John.ZAJICEK@phnt.swest.nhs.uk |
Study information
| Study design | Multi-centre randomised double-blind placebo-controlled two-arm parallel study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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) |
| Study acronym | MUSEC |
| Study hypothesis | 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. |
| Ethics approval(s) | Multi-centre Research Ethics Committee For Scotland, 31/01/2006, ref: 05/MRE10/97 |
| Condition | Multiple sclerosis |
| Intervention | 1. Cannabis extract (delta-9-tetrahydrocannabinol [THC] 2.5 mg, Cannabidiol [CBD] 1.25 mg per capsule) - start dose 5 mg THC per day, followed by individual dose titration with increase of 5 mg THC every 3 days, maximal dose 25 mg, administered orally as 2 equal doses per day based on tolerability 2. Matched placebo There is no follow up for the trial (total duration of trial is 12 weeks from randomisation). Added 12/09/2008: Recruitment for the MUSEC Study has now been completed. Last patient randomised was 04/09/2008. The Last Patient Last Visit is expected in November 2008. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Cannabis sativa extract |
| Primary outcome measure | Change in muscle stiffness: 11-point numerical Likert scale, measured at 12 weeks. |
| Secondary outcome measures | 1. Change in pain: 11-point numerical Likert scale, measured at 12 weeks 2. Amount of muscle stiffness: 11-point numerical Likert scale, measured at 2, 4, 8 and 12 weeks 3. Amount of pain: 11-point numerical Likert scale, measured at 2, 4, 8 and 12 weeks 4. Change/amount of spasms: 11-point numerical Likert scales, measured at 2, 4, 8 and 12 weeks 5. Change/amount of sleep disturbance: 11-point numerical Likert scales, measured at 2, 4, 8 and 12 weeks 6. Disease-specific Quality of Life: Multiple Sclerosis Spasticity Scale (MSSS)-88 and Multiple Sclerosis Impact Scale (MSIS)-29, measured at 4 and 12 weeks 7. Patient-rated walking ability: Multiple Sclerosis Walking Scale (MSWS)-12, measured at 4 and 12 weeks |
| Overall study start date | 20/06/2006 |
| Overall study end date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | Both |
| Target number of participants | 400 |
| Participant inclusion criteria | 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 |
| Participant exclusion criteria | 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 |
| Recruitment start date | 20/06/2006 |
| Recruitment end date | 30/06/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Peninsula Medical School
Plymouth
PL6 8BX
United Kingdom
PL6 8BX
United Kingdom
Sponsor information
Institute for Clinical Research (Institut fur klinische Forschung) (Germany)
Research organisation
Research organisation
Hardenbergstr. 19
Berlin
D-10623
Germany
| Phone | +49 (0)30 315 744 71 |
|---|---|
| martin.schnelle@ikf-berlin.de | |
| Website | http://www.ikf-berlin.de |
Funders
Funder type
Industry
Weleda AG (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2012 | Yes | No |
