Multiple sclerosis Nervous System Diseases Multiple sclerosis
Conditions
Interventions
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. Pl
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Ashworth score | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed