The Effect of Cannabidiol for Restless Legs Syndrome/Willis-Ekbom Disease in Parkinson’s Disease Patients with REM Sleep Behavior Disorder: A Exploratory Analysis of Phase 2/3 Clinical Trial.

Cannabidiol (CBD) is one of the main nonpsychoactive components of and may represent an alternative treatment for Restless Legs Syndrome/Willis-Ekbom Disease (RLS/WED) in patients with Parkinson's disease (PD) and REM (Rapid Eye Movement) sleep behavior disorder (RBD). Our purpose was a exploratory analysis to evaluate the CBD's efficacy to improve the severity of RLS/WED symptoms in patients with PD and RBD. A exploratory analysis of a phase II/III, a parallel, double-blind, placebo-controlled clinical trial was conducted in 18 patients with RLS/WED and PD plus RBD associated. Six patients were randomized to the CBD group in doses of 75-300 mg, and twelve received placebo capsules. They were followed up for 14 weeks. The primary outcome was the severity of RLS/WED by Restless Legs Syndrome Rating Scale of the International Restless Legs Syndrome Study Group (IRLSSG). CBD showed no difference in relationship to placebo for primary and secondary outcomes. CBD showed no reduction in the severity of RLS/WED manifestation in patients with PD and RBD.