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

Author(s)

de Almeida, Carlos Mauricio Oliveira ; Brito, Manuelina Mariana Capellari ; Bosaipo, Nayanne Beckmann ; Pimentel, Angela Vieira ; Sobreira-Neto, Manoel Alves ; Tumas, Vitor ; Zuardi, Antonio Waldo ; Crippa, Jose Alexandre de Souza ; Hallak, Jaime Eduardo Cecilio ; Eckeli, Alan Luiz

• Document type: Journal article
• Source: CANNABIS AND CANNABINOID RESEARCH; v. N/A, p. 5-pg., 2022-06-24.

Abstract

Background: Cannabidiol (CBD) is one of the main nonpsychoactive components of Cannabis sativa 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).Objective: Our purpose was a post hoc exploratory analysis to evaluate the CBD's efficacy to improve the severity of RLS/WED symptoms in patients with PD and RBD.Methods: A post hoc 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).Results: CBD showed no difference in relationship to placebo for primary and secondary outcomes.Conclusion: CBD showed no reduction in the severity of RLS/WED manifestation in patients with PD and RBD. (AU)

• FAPESP's process: 08/09009-2 - Crack/cocaine chronic use: dopamine transporters availability, genetic factors, and executive functioning
• Grantee: Acioly Luiz Tavares de Lacerda
• Support Opportunities: Regular Research Grants