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Multiple sclerosis and extract of cannabis: results of the MUSEC trial.
J Neurol Neurosurg Psychiatry 2012; 83(11):1125-32JN

Abstract

OBJECTIVE

Multiple sclerosis (MS) is associated with chronic symptoms, including muscle stiffness, spasms, pain and insomnia. Here we report the results of the Multiple Sclerosis and Extract of Cannabis (MUSEC) study that aimed to substantiate the patient based findings of previous studies.

PATIENTS AND METHODS

Patients with stable MS at 22 UK centres were randomised to oral cannabis extract (CE) (N=144) or placebo (N=135), stratified by centre, walking ability and use of antispastic medication. This double blind, placebo controlled, phase III study had a screening period, a 2 week dose titration phase from 5 mg to a maximum of 25 mg of tetrahydrocannabinol daily and a 10 week maintenance phase. The primary outcome measure was a category rating scale (CRS) measuring patient reported change in muscle stiffness from baseline. Further CRSs assessed body pain, spasms and sleep quality. Three validated MS specific patient reported outcome measures assessed aspects of spasticity, physical and psychological impact, and walking ability.

RESULTS

The rate of relief from muscle stiffness after 12 weeks was almost twice as high with CE than with placebo (29.4% vs. 15.7%; OR 2.26; 95% CI 1.24 to 4.13; p=0.004, one sided). Similar results were found after 4 weeks and 8 weeks, and also for all further CRSs. Results from the MS scales supported these findings.

CONCLUSION

The study met its primary objective to demonstrate the superiority of CE over placebo in the treatment of muscle stiffness in MS. This was supported by results for secondary efficacy variables. Adverse events in participants treated with CE were consistent with the known side effects of cannabinoids. No new safety concerns were observed.

TRIAL REGISTRATION NUMBER

NCT00552604.

Authors+Show Affiliations

Clinical Neurology Research Group, Peninsula College of Medicine and Dentistry, University of Plymouth, Derriford, UK. john.zajicek@nhs.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22791906

Citation

Zajicek, John Peter, et al. "Multiple Sclerosis and Extract of Cannabis: Results of the MUSEC Trial." Journal of Neurology, Neurosurgery, and Psychiatry, vol. 83, no. 11, 2012, pp. 1125-32.
Zajicek JP, Hobart JC, Slade A, et al. Multiple sclerosis and extract of cannabis: results of the MUSEC trial. J Neurol Neurosurg Psychiatry. 2012;83(11):1125-32.
Zajicek, J. P., Hobart, J. C., Slade, A., Barnes, D., & Mattison, P. G. (2012). Multiple sclerosis and extract of cannabis: results of the MUSEC trial. Journal of Neurology, Neurosurgery, and Psychiatry, 83(11), pp. 1125-32. doi:10.1136/jnnp-2012-302468.
Zajicek JP, et al. Multiple Sclerosis and Extract of Cannabis: Results of the MUSEC Trial. J Neurol Neurosurg Psychiatry. 2012;83(11):1125-32. PubMed PMID: 22791906.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multiple sclerosis and extract of cannabis: results of the MUSEC trial. AU - Zajicek,John Peter, AU - Hobart,Jeremy C, AU - Slade,Anita, AU - Barnes,David, AU - Mattison,Paul G, AU - ,, Y1 - 2012/07/12/ PY - 2012/7/14/entrez PY - 2012/7/14/pubmed PY - 2013/1/12/medline SP - 1125 EP - 32 JF - Journal of neurology, neurosurgery, and psychiatry JO - J. Neurol. Neurosurg. Psychiatry VL - 83 IS - 11 N2 - OBJECTIVE: Multiple sclerosis (MS) is associated with chronic symptoms, including muscle stiffness, spasms, pain and insomnia. Here we report the results of the Multiple Sclerosis and Extract of Cannabis (MUSEC) study that aimed to substantiate the patient based findings of previous studies. PATIENTS AND METHODS: Patients with stable MS at 22 UK centres were randomised to oral cannabis extract (CE) (N=144) or placebo (N=135), stratified by centre, walking ability and use of antispastic medication. This double blind, placebo controlled, phase III study had a screening period, a 2 week dose titration phase from 5 mg to a maximum of 25 mg of tetrahydrocannabinol daily and a 10 week maintenance phase. The primary outcome measure was a category rating scale (CRS) measuring patient reported change in muscle stiffness from baseline. Further CRSs assessed body pain, spasms and sleep quality. Three validated MS specific patient reported outcome measures assessed aspects of spasticity, physical and psychological impact, and walking ability. RESULTS: The rate of relief from muscle stiffness after 12 weeks was almost twice as high with CE than with placebo (29.4% vs. 15.7%; OR 2.26; 95% CI 1.24 to 4.13; p=0.004, one sided). Similar results were found after 4 weeks and 8 weeks, and also for all further CRSs. Results from the MS scales supported these findings. CONCLUSION: The study met its primary objective to demonstrate the superiority of CE over placebo in the treatment of muscle stiffness in MS. This was supported by results for secondary efficacy variables. Adverse events in participants treated with CE were consistent with the known side effects of cannabinoids. No new safety concerns were observed. TRIAL REGISTRATION NUMBER: NCT00552604. SN - 1468-330X UR - https://www.unboundmedicine.com/medline/citation/22791906/Multiple_sclerosis_and_extract_of_cannabis:_results_of_the_MUSEC_trial_ L2 - http://jnnp.bmj.com/cgi/pmidlookup?view=long&pmid=22791906 DB - PRIME DP - Unbound Medicine ER -