A multiple randomised controlled trial of cannabinoids on spasticity in multiple sclerosis (MS)

ISRCTN ISRCTN39371386
DOI https://doi.org/10.1186/ISRCTN39371386
Protocol serial number G9900990
Sponsor Medical Research Council (MRC) (UK)
Funder Medical Research Council (MRC) (UK)
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

Department of Neurology
Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleA multiple randomised controlled trial of cannabinoids on spasticity in multiple sclerosis (MS)
Study objectivesThe 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) studiedMultiple sclerosis
InterventionPatients 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 typeOther
Primary outcome measure(s)Changes in Ashworth score
Key secondary outcome measure(s)Not provided at time of registration
Completion date31/03/2003

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit64 Years
SexAll
Target sample size at registration660
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2000
Date of final enrolment10/10/2002

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Derriford Hospital
Plymouth
PL6 8DH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
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