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

Authors

  • C. Collin,

    1. Department of Neurorehabilitation, Royal Berkshire and Battle NHS Trust, Reading, UK
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  • P. Davies,

    1. Department of Neurology, Northampton General Hospital, Northampton, UK
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  • I. K. Mutiboko,

    1. Trial-Link Ltd, Bexhill-on-Sea, UK
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  • S. Ratcliffe,

    1. Barts Pain Research Group, Barts and The London NHS Trust, London, UK
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  • for the Sativex Spasticity in MS Study Group

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    • *

      The Sativex® Spasticity in MS Study Group comprise the following: Dr C. H. Hawkes, Oldchurch Hospital, Romford, UK; Prof. C. Hawkins, University Hospital of North Staffordshire NHS Trust, Stoke-On-Trent, UK; Dr R. Stevens, Amersham General Hospital, Amersham, UK; Dr W. Notcutt, James Paget Hospital, Great Yarmouth, UK; Dr D. Minea, Spitalul de Neuropsihiatrie, Brasov, Romania; Dr C. Zaharia, Spitalul Clinic de Neuropsihiatrie, Craiova, Romania; Dr M. Pereanu, Spitalul Clinic, Judetean Sibiu Sectia, Sibiu, Romania; Dr C. Protosevici, Spitalul Clinic, Bucuresti, Romania; Dr Stephen Wright, Richard Potts, Rebecca McCalla, and Paul Duncombe, GW Pharmaceuticals Plc, Salisbury, UK.


Christine Collin, Department of Neurorehabilitation, Royal Berkshire and Battle NHS Trust, London Road Reading, Berkshire RG1 5AN, UK (tel.: 0118 322 5367; fax: 0118 322 6751; e-mail: christine.collin@rbbh-tr.nhs.uk).

Abstract

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.

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