Condition category
Nervous System Diseases
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
12/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr John Zajicek

ORCID ID

Contact details

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

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes