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ISRCTN
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ISRCTN39371386
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DOI
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10.1186/ISRCTN39371386
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A multiple randomised controlled trial of cannabinoids on spasticity in multiple sclerosis (MS)
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Scientific title
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Acronym
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N/A
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Serial number at source
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G9900990
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Multiple sclerosis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/12/2000
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Anticipated end date
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31/03/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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660
Added 07/09/09: recruitment closed 10/10/02
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Interventions
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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
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Primary outcome measure(s)
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Changes in Ashworth score
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14615106
2. 2005 follow up results at 12 months in http://www.ncbi.nlm.nih.gov/pubmed/16291891
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Contact name
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Dr
John
Zajicek
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Address
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Department of Neurology
Derriford Hospital
Derriford Road
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City/town
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Plymouth
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Zip/Postcode
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PL6 8DH
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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23/10/2000
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Last edited
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07/09/2009
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Date ISRCTN assigned
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23/10/2000
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