MUSEC (Multiple Sclerosis and Extract of Cannabis)
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MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study

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Registry of Trials clinicaltrials.gov
Year 2006
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Study Objectives: To determine the efficacy and safety of a standardised extract of Cannabis sativa given orally 2 times daily as compared to placebo for the relief of muscle stiffness and pain in multiple sclerosis for a period of 12 weeks. Study Patients: 400 patients with multiple sclerosis (age 18-64, stable disease during previous 6 months, ambulatory or not, antispasticity medication and physiotherapy stabilised ≥ 30 days) with experiencing muscle stiffness ≥ 4 on a 11-point numerical Likert scale at baseline. Study treatment: Group 1: Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily, additionally to previous antispasticity and analgesic medication. Group 2: Matched placebo, twice daily, additionally to previous antispasticity and analgesic medication. Treatment Schedule: Start dose 5 mg THC/d, individual dose titration with increase of 5 mg THC every 3 days, maximal total daily dose 25 mg THC, administered as 2 equal doses based on tolerability. Treatment duration: 12 weeks. Study sites: 20 neurological clinics in the United Kingdom.

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Multiple Sclerosis and Extract of Cannabis (MUSEC): a randomised, double-blind, placebo-controlled phase III trial to determine the efficacy and safety of a standardised oral extract of cannabis sativa for the symptomatic relief of muscle stiffness and pa...

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Registry of Trials EU Clinical Trial
Year 2006
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005263-29

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Cannabis extract in the treatment of muscle stiffness and other symptoms in multiple sclerosis-Results of the MUSEC study

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Authors ZAJICEK , J.; REIF , M.; SCHNELLE , M
Journal Multiple Sclerosis
Year 2009
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UK MUSEC Study Investigators. Cannabis extract in the treatment of muscle stiffness and other symptoms in multiple sclerosis – results of the MUSEC study

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Authors Zajicek, J , Reif, M , Schnelle, M
Conference IACM 5th Conference on Cannabinoids in Medicine
Year 2009
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Cannabis extract in the treatment of muscle stiffness and other symptoms in multiple sclerosis—Results of the MUSEC study

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Authors Zajicek J , Reif M , Schnelle M
Conference 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis
Year 2009
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Mult Scler. 2009;15(9)(suppl S):S274

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Multiple sclerosis and extract of cannabis: results of the MUSEC trial.

Journal Journal of neurology, neurosurgery, and psychiatry
Year 2012
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<b>OBJECTIVE: </b>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.<b>Patients and METHODS: </b>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.<b>RESULTS: </b>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.<b>CONCLUSION: </b>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.<b>Trial Registration Number: </b>NCT00552604.

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Cannabis as a symptomatic treatment for MS: Clinically meaningful MUSEC to the stiffness and walking problems of people with MS

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Authors Hobart JC , Zajicek JP
Conference 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis. Published in: Multiple Sclerosis Journal. 2012;18(4 SUPPL. 1):247
Year 2012
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Background: The Multiple Sclerosis and Extract of Cannabis (MUSEC) study was a randomised, double-blind, placebo-controlled phase III trial to determine the efficacy and safety of a standardised oral extract of Cannabis sativa for the symptomatic relief of muscle stiffness and pain in MS. The primary outcome measure was a category rating scale (CRS) measuring patient-reported change in muscle stiffness from baseline. The study met its primary objective to demonstrate superiority of cannabis extract over placebo in treatment of muscle stiffness in MS, and no new safety concerns were observed. We now report results from the secondary patient-reported outcomes measures: the MS Spasticity Scale (MSSS-88), MS Walking Scale (MSWS-12), and the MS Impact Scale (MSIS-29) Methods: Patients with stable MS at 22 UK centres were randomised to oral cannabis extract (N=144) or placebo (N=135), stratified by centre, walking ability and use of antispastic medication. There was a screening period, a 2-week dose titration phase from 5mg to a maximum of 25mg tetrahydrocannabinol (THC) daily, and a 10-week maintenance phase. Rating scale data were analysed using Rasch measurement methods. We report impact above and beyond placebo using widely accepted approximate thresholds for clinical meaningful effect sizes (ES; small=0.20; moderate=0.50; large = 0.8). Results: There were differential effects across the different outcomes. Essentially, people reported: clinically moderate benefits on muscle stiffness (ES= 0.44) and walking ability (ES=0.46); clinically mildto- moderate benefits on body movements (ES=0.36); clinically small benefits on pain/discomfort and physical impact (both ES=0.20). No clinically meaningful benefits were demonstrated on muscle spasms (ES=0.13) and activities of daily living (ES = 0.01). Of note there were no effects above placebo on people’s feelings (ES=0.01), psychological impact (ES=-0.03), and social functioning (ES=0.01). Conclusions: Results imply cannabis in MS reduces muscle stiffness and improves walking ability, and to a lesser extent improves body movements and reduces pain and physical impact. The lack of a psychosocial effect, coupled with the differential effects across outcomes appears to dispel the myth that the benefit of cannabis in MS is simply because it makes people feel better.