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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 17 October 2016
Main ID:  ISRCTN39371386
Date of registration: 23/10/2000
Prospective Registration: Yes
Primary sponsor: Medical Research Council (MRC) (UK)
Public title: A multiple randomised controlled trial of cannabinoids on spasticity in multiple sclerosis (MS)
Scientific title: A multiple randomised controlled trial of cannabinoids on spasticity in multiple sclerosis (MS)
Date of first enrolment: 01/12/2000
Target sample size: 660
Recruitment status: Completed
Study type:  Interventional
Study design:  Randomised controlled trial (Treatment)  
Countries of recruitment
United Kingdom
Name: John    Zajicek
Address:  Department of Neurology Derriford Hospital Derriford Road PL6 8DH Plymouth United Kingdom
Key inclusion & exclusion 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: 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.

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Multiple sclerosis
Nervous System Diseases
Multiple sclerosis
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
Primary Outcome(s)
Changes in Ashworth score
Secondary Outcome(s)
Not provided at time of registration
Secondary ID(s)
Source(s) of Monetary Support
Medical Research Council (MRC) (UK)
Secondary Sponsor(s)
Results available:
Date Posted:
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