Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9900990
Study information
Scientific title
A multiple randomised controlled trial of cannabinoids on spasticity in multiple sclerosis (MS)
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Multiple sclerosis
Intervention
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
Intervention type
Other
Phase
Drug names
Primary outcome measure
Changes in Ashworth score
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2000
Overall trial end date
31/03/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
660
Participant 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.
Recruitment start date
01/12/2000
Recruitment end date
10/10/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
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Results
Zajicek J, Fox P, Sanders H, Wright D, Vickery J, Nunn A, Thompson A, , Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial., Lancet, 2003, 362, 9395, 1517-1526, doi: 10.1016/S0140-6736(03)14738-1.
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Zajicek JP, Sanders HP, Wright DE, Vickery PJ, Ingram WM, Reilly SM, Nunn AJ, Teare LJ, Fox PJ, Thompson AJ, Cannabinoids in multiple sclerosis (CAMS) study: safety and efficacy data for 12 months follow up., J. Neurol. Neurosurg. Psychiatr., 2005, 76, 12, 1664-1669, doi: 10.1136/jnnp.2005.070136.