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Sativex(®) and clinical-neurophysiological measures of spasticity in progressive multiple sclerosis.

Abstract
Despite the proven efficacy of Sativex(®) (9-delta-tetrahydrocannabinol plus cannabidiol) oromucosal spray in reducing spasticity symptoms in multiple sclerosis (MS), little is known about the neurophysiological correlates of such effects. The aim of the study was to investigate the effects of Sativex on neurophysiological measures of spasticity (H/M ratio) and corticospinal excitability in patients with progressive MS. This was a randomized, double-blind, placebo-controlled, crossover study. Consecutive subjects with progressive MS and lower limb spasticity referred to our center were randomized to 4 weeks' treatment (including 2 weeks' titration) with Sativex or placebo, with crossover after a 2-week washout. Clinical and neurophysiological measures (H/M ratio and cortical excitability) of spasticity were assessed. The H/M ratio was the primary outcome, with sample size calculation of 40 patients. Of 44 recruited patients, 34 were analyzed due to 6 drop-outs and 4 exclusions, which lowered the power of the study to show differences between treatments. Neurophysiological measures did not differ significantly according to treatment and did not correlate significantly with clinical response. Response on the modified Ashworth scale (at least 20 % improvement) was significantly more frequent after Sativex than placebo (50 vs 23.5 %; p = 0.041; McNemar). Side effects did not differ significantly according to treatment. Our findings confirm the clinical benefit of Sativex on MS spasticity. The lack of corresponding changes in corticospinal excitability and on the monosynaptic component, of the stretch reflex, although in a limited sample size, points to the involvement of other spinal and supraspinal mechanisms in the physiopathology of spasticity in progressive MS.
AuthorsLetizia Leocani, Arturo Nuara, Elise Houdayer, Irene Schiavetti, Ubaldo Del Carro, Stefano Amadio, Laura Straffi, Paolo Rossi, Vittorio Martinelli, Carlos Vila, Maria Pia Sormani, Giancarlo Comi
JournalJournal of neurology (J Neurol) Vol. 262 Issue 11 Pg. 2520-7 (Nov 2015) ISSN: 1432-1459 [Electronic] Germany
PMID26289497 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Drug Combinations
  • Plant Extracts
  • Cannabidiol
  • Dronabinol
  • nabiximols
Topics
  • Adult
  • Cannabidiol
  • Cerebral Cortex (drug effects)
  • Cross-Over Studies
  • Double-Blind Method
  • Dronabinol
  • Drug Combinations
  • Electric Stimulation
  • Electromyography
  • Evoked Potentials, Motor (drug effects)
  • Female
  • Humans
  • Male
  • Middle Aged
  • Multiple Sclerosis, Chronic Progressive (complications, drug therapy)
  • Muscle Spasticity (drug therapy, etiology)
  • Outcome Assessment, Health Care
  • Plant Extracts (administration & dosage, adverse effects, pharmacology)
  • Severity of Illness Index
  • Transcranial Magnetic Stimulation

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