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Randomized controlled trial of cannabis‐based medicine in spasticity caused by multiple sclerosis
Author(s) -
Collin C.,
Davies P.,
Mutiboko I. K.,
Ratcliffe S.
Publication year - 2007
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/j.1468-1331.2006.01639.x
Subject(s) - spasticity , medicine , tolerability , placebo , clinical endpoint , randomized controlled trial , modified ashworth scale , cannabidiol , adverse effect , multiple sclerosis , cannabis , rating scale , population , physical therapy , delta 9 tetrahydrocannabinol , tetrahydrocannabinol , clinical trial , psychiatry , alternative medicine , psychology , cannabinoid , developmental psychology , environmental health , receptor , pathology
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.