A multiple randomised controlled trial of cannabinoids on spasticity i
A multiple randomised controlled trial of cannabinoids on spasticity in multiple sclerosis (MS)
What it found
A paper reports the results; we have not read it yet. See Papers below.
What it measured
Main measures
Changes in Ashworth score
Spasticity
Other measures (1)
Not provided at time of registration
Who could take part
MS (type not specified) · 18 to 64
Show the full criteria
Inclusion criteria
Inclusion: 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: 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.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Not provided at time of registration
Papers
Results
resultsResults
follow up results at 12 months
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History
Started
Dec 2000
Finished
Mar 2003