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Cannabinoids in Multiple Sclerosis Trial Fully Recruited

October 11, 2002

On Monday the Peninsula Medical School will announce that the Medical Research Council sponsored trial investigating the effectiveness of cannabinoids on the symptoms of Multiple Sclerosis has fully recruited its quota of 667 patients.

Dr John Zajicek, consultant neurologist and one of the Principal Investigators of the study, said: "There has been great enthusiasm from the Multiple Sclerosis community for this trial. This is the first opportunity many patients have had to be involved in a comprehensive assessment of treatment for MS. It is great to have fully recruited a statistically meaningful trial group.




"There has been widespread interest in this trial from the general public through to the House of Lords. Many of us are aware of the potential impact of this study, not only on our understanding of the mechanisms of cannabinoid action, but also on improving the quality of life for people with MS."

Multiple Sclerosis is the commonest cause of neurological disability in young adults. Of the many symptoms frequently encountered in MS, muscle spasticity (stiffness) and spasms occur in up to 90% of patients at some point in their illness.

Current therapies for spasticity often provide inadequate relief and are limited by side effects. Anecdotal reports suggested that the drug cannabis (the use of which is currently illegal) and its derivatives (cannabinoids) are a useful alternative treatment for muscle spasticity. However, there is only limited scientific evidence to support this fact.

In order to establish whether there was scientific proof behind the anecdotal reports of the medical effectiveness of these drugs in MS, proposals for a Multicentre randomised placebo-controlled trial were drawn up by a team of investigators based at the Peninsula Medical School. This followed work coordinated by the Royal Pharmaceutical Society and two reports from the House of Lords Science and Technology Committee, both bodies being helpful in getting the trial off the ground. The study required licences from the Home Office and Medicines Control Agency and funding from the Medical Research Council in London. The trial started in January 2001 when 44 Plymouth patients were recruited to the research programme, in which medication could be taken for up to one year. In June 2001, recruitment was extended to 33 centres nationwide.

On Monday 14 October Dr John Zajicek will announce that the research has successfully reached its trial capacity, exactly in line with planned patient recruitment. 667 people have been successfully recruited from trial centres as far afield as Sheffield, Belfast, Lincoln, London, Manchester, Swansea, Cambridge and Dundee. Trial staff are collecting data and results will be analysed at the Peninsula Medical School.   

Patients taking part have been randomly allocated by computer to one of three treatments: cannabis oil (prepared from the cannabis plant containing a balance of all the chemicals present in the plant), tetrahydrocannabinol (containing a single chemical compound which is found in the cannabis plant) or placebo capsules. The study is blinded so that neither patients nor doctors know which form of treatment is being taken. Assessments of muscle stiffness and mobility are made every few weeks, and patients also provide information via postal surveys about their quality of life.

The research aims to establish whether cannabis is effective in reducing muscle stiffness and improving mobility in patients with MS. It is the largest single study of symptom treatment in MS ever performed. The main phase of the trial will be complete for patients in February 2003 when the data analysis will commence. Current plans are to complete the final report on the effect of cannabis on symptoms of Multiple Sclerosis in June 2003.

-ends-

Peninsula Medical School



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