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

Eur J Neurol. 2007 Mar;14(3):290-6. doi: 10.1111/j.1468-1331.2006.01639.x.

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.

Publication types

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

MeSH terms

  • Administration, Oral
  • Adult
  • Cannabidiol / administration & dosage
  • Cannabidiol / adverse effects
  • Cannabinoids / administration & dosage*
  • Cannabinoids / adverse effects
  • 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 / 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
  • Treatment Outcome

Substances

  • Cannabinoids
  • Placebos
  • Plant Extracts
  • Cannabidiol
  • Dronabinol