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

摘要: Despite the proven efficacy of Sativex(®) (9-delta-tetrahydrocannabinol plus cannabidiol) oromucosal spray in reducing spasticity symptoms multiple sclerosis (MS), little is known about neurophysiological correlates such effects. The aim study was to investigate effects Sativex on measures (H/M ratio) and corticospinal excitability patients with progressive MS. This a randomized, double-blind, placebo-controlled, crossover study. Consecutive subjects MS lower limb referred our center were randomized 4 weeks' treatment (including 2 titration) or placebo, after 2-week washout. Clinical ratio cortical excitability) assessed. H/M primary outcome, sample size calculation 40 patients. Of 44 recruited patients, 34 analyzed due 6 drop-outs exclusions, which lowered power show differences between treatments. Neurophysiological did not differ significantly according correlate clinical response. Response modified Ashworth scale (at least 20 % improvement) more frequent than placebo (50 vs 23.5 %; p = 0.041; McNemar). Side treatment. Our findings confirm benefit spasticity. lack corresponding changes monosynaptic component, stretch reflex, although limited size, points involvement other spinal supraspinal mechanisms physiopathology