Advances in the management of multiple sclerosis spasticity: recent clinical trials

Eur Neurol. 2014;72 Suppl 1:9-11. doi: 10.1159/000367616. Epub 2014 Sep 26.

Abstract

Background: Most patients with multiple sclerosis (MS) experience spasticity as the clinical course evolves. Associated symptoms include (often painful) spasms, urinary dysfunction and sleep disturbances. THC:CBD oromucosal spray (Sativex®) is approved for symptom improvement in adult patients with moderate to severe MS-related spasticity who have not responded adequately to other antispasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy.

Summary: In pivotal clinical trials of THC:CBD oromucosal spray, a meaningful proportion of patients with treatment-resistant MS spasticity achieved clinically relevant improvement with active treatment versus placebo. The utility of a 4-week trial of therapy to identify patients who respond to treatment was demonstrated in an enriched-design study. THC:CBD oromucosal spray was well tolerated in these studies, with no evidence of effects typically associated with recreational cannabis use. In a subsequent post approval clinical trial, THC:CBD oromucosal spray had no statistically significant effect on cognition and mood compared with placebo. Moreover, after 50 weeks' treatment, approximately two-thirds of patients, physicians and caregivers reported improvement from baseline in spasticity based on global impressions of change. Key Messages: In phase III clinical trials, approximately one-third of MS patients with treatment-resistant spasticity had a clinically relevant and statistically significant response to THC:CBD oromucosal spray. In addition to a reduction in spasticity, responders experienced meaningful relief from associated symptoms. THC:CBD oromucosal spray was generally well tolerated and efficacy was maintained over the longer term. A post-approval clinical trial indicated no effect of THC:CBD oromucosal spray on cognition or mood after 50 weeks of use.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Affect / drug effects
  • Cannabidiol
  • Clinical Trials, Phase III as Topic*
  • Cognition / drug effects
  • Dronabinol
  • Drug Combinations
  • Humans
  • Multiple Sclerosis / drug therapy*
  • Multiple Sclerosis / physiopathology
  • Multiple Sclerosis / psychology
  • Muscle Relaxants, Central / therapeutic use*
  • Muscle Spasticity / drug therapy*
  • Muscle Spasticity / physiopathology
  • Plant Extracts / therapeutic use*
  • Randomized Controlled Trials as Topic

Substances

  • Drug Combinations
  • Muscle Relaxants, Central
  • Plant Extracts
  • Cannabidiol
  • Dronabinol
  • nabiximols