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

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 delta-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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  • Publisher Full Text
  • Authors

    Collin C, Davies P, Mutiboko IK, Ratcliffe S, Sativex Spasticity in MS Study Group

    Source

    MeSH

    Administration, Oral
    Adult
    Cannabidiol
    Cannabinoids
    Central Nervous System
    Double-Blind Method
    Dronabinol
    Female
    Humans
    Male
    Middle Aged
    Multiple Sclerosis
    Muscle Spasticity
    Placebos
    Plant Extracts
    Treatment Outcome

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    17355549