A multiple randomised controlled trial of cannabinoids on spasticity in multiple sclerosis (MS)
| ISRCTN | ISRCTN39371386 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39371386 |
| Secondary identifying numbers | G9900990 |
- Submission date
- 23/10/2000
- Registration date
- 23/10/2000
- Last edited
- 12/06/2015
- 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 of protocol
Not provided at time of registration
Contact information
Dr John Zajicek
Scientific
Scientific
Department of Neurology
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A multiple randomised controlled trial of cannabinoids on spasticity in multiple sclerosis (MS) |
| Study objectives | The hypothesis is that cannabinoids have a beneficial therapeutic effect on spasticity in MS, and may also have beneficial effects on pain, tremor, micturition disturbance and overall measures of quality of life. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Multiple sclerosis |
| Intervention | Patients will be randomly assigned to one of four regimens in the ratio 2:1:2:1, as follows: 1. THC (Marinol) (maximum total daily dose 0.25 mg/kg in equal doses, given as 2.5 mg THC capsules) 2. Placebo capsules (containing oil vehicle) matched to appearance of THC 3. Natural cannabis oil (Cannador) containing the same dose of THC, made up to GMP standard 4. Placebo capsules (containing oil vehicle) matched to appearance of the cannabis capsules |
| Intervention type | Other |
| Primary outcome measure | Changes in Ashworth score |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/12/2000 |
| Completion date | 31/03/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | Both |
| Target number of participants | 660 |
| Key inclusion criteria | 1. Clinically definite or laboratory supported MS aged 18-64 years inclusive 2. Significant spasticity in at least 2 lower limb muscle groups (Ashworth score of 2 or more, in two or more muscle groups, eg left foot plantar flexion & left knee & right knee flexors, etc) 3. Stable disease for previous 6 months in the opinion of the treating physician 4. Antispasticity medication and physiotherapy stabilised for the last 30 days 5. Patients may be ambulatory or not |
| Key exclusion criteria | 1. Immunosuppression, including corticosteroids or interferon taken currently or in previous 30 days. 2. Past or present history of ischaemic heart disease or psychotic illness 3. Other serious illness likely to interfere with study assessment such as major organ failure, neoplasia, coeliac disease - see appendix 9 and if in doubt please contact the Plymouth Trial Coordinating Centre (PTCC) . 4. Open/ infected pressure sores or other source of chronic infection. 5. Significant fixed tendon contractures. 6. Severe cognitive impairment such that patient is unable to provide informed consent. 7. Women who are pregnant, lactating or not using adequate contraception. 8. Unwilling to stop driving or operating dangerous machinery for the study period and one week afterwards. 9. Cannabinoids taken currently or in previous 30 days. 10. Previous use of THC (Marinol) at any time. 11. Anticipated foreign travel within the first 15 weeks of the trial. 12. Anticipated immunisations within the first 15 weeks of the trial. 13. Participation in other research studies currently or within previous 3 months. 14. Other problems likely to make participation difficult at the discretion of the neurologist. |
| Date of first enrolment | 01/12/2000 |
| Date of final enrolment | 10/10/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 | 08/11/2003 | Yes | No | |
| Results article | follow up results at 12 months | 01/12/2005 | Yes | No |
