Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis

• Published in: European journal of neurology Vol. 14; no. 3; pp. 290 - 296
• Main Authors: Collin, C., Davies, P., Mutiboko, I. K., Ratcliffe, S.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.03.2007
• Subjects: Administration, Oral; Adult; Cannabidiol - administration & dosage; Cannabidiol - adverse effects; Cannabinoids - administration & dosage; Cannabinoids - adverse effects; cannabis-based medicine; Central Nervous System - drug effects; Central Nervous System - physiopathology; Double-Blind Method; Dronabinol - administration & dosage; Dronabinol - adverse effects; Female; Humans; Male; Middle Aged; multiple sclerosis; Multiple Sclerosis - complications; Multiple Sclerosis - drug therapy; Multiple Sclerosis - physiopathology; Muscle Spasticity - drug therapy; Muscle Spasticity - etiology; Muscle Spasticity - physiopathology; Placebos; Plant Extracts - administration & dosage; Plant Extracts - adverse effects; Sativex; spasticity; Treatment Outcome
• DOI: 10.1111/j.1468-1331.2006.01639.x
• ISSN: 1351-5101; 1468-1331

Symptoms relating to spasticity are common in multiple sclerosis (MS) and can be difficult to treat. We have investigated the efficacy, safety and tolerability of a standardized oromucosal whole plant cannabis‐based medicine (CBM) containing Δ‐9 tetrahydrocannabinol (THC) and cannabidiol (CBD), upon spasticity in MS. A total of 189 subjects with definite MS and spasticity were randomized to receive daily doses of active preparation (n = 124) or placebo (n = 65) in a double blind study over 6 weeks. The primary endpoint was the change in a daily subject‐recorded Numerical Rating Scale of spasticity. Secondary endpoints included a measure of spasticity (Ashworth Score) and a subjective measure of spasm. The primary efficacy analysis on the intention to treat (ITT) population (n = 184) showed the active preparation to be significantly superior (P = 0.048). Secondary efficacy measures were all in favour of active preparation but did not achieve statistical significance. The responder analysis favoured active preparation, 40% of subjects achieved >30% benefit (P = 0.014). Eight withdrawals were attributed to adverse events (AEs); six were on active preparation and two on placebo. We conclude that this CBM may represent a useful new agent for treatment of the symptomatic relief of spasticity in MS.