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Study register · detail RCT · Parkinson Disease · 2023

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.

de Almeida et al. ·Cannabis and cannabinoid research Impact 2.5
No benefit demonstrated GRADE Moderate 12 citations
Samplen = 18 Pat.
Duration14 weeks
ControlPlacebo capsules
EndpointIRLSSG scale
Blindingdoppelblind
DesignRCT
Cannabinoidcbd
Max. dose300.0 mg
Routeoral
Key finding

CBD showed no difference from placebo in reducing RLS/WED severity in patients with Parkinson's and RBD.

Summary

Post-hoc analysis of a phase II/III RCT (n=18) of CBD (75-300 mg) vs. placebo in Parkinson's patients with RBD and restless legs syndrome; CBD showed no difference from placebo for the IRLSSG severity score after 14 weeks of follow-up.

P
PopulationParkinson's patients with REM sleep behaviour disorder (RBD) and restless legs syndrome/Willis-Ekbom disease (RLS/WED), n=18
I
InterventionCannabidiol (CBD), oral, 75–300 mg/day, 14 weeks
C
ControlPlacebo capsules
O
OutcomeNo significant difference between CBD and placebo regarding RLS/WED severity (IRLSSG)
Confidence in the evidence
Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for
Imprecision
Quality profile
Sample size ★★★★★
Blinding Double-blind
Effect size No benefit
Citations / year ★★★★★
Authors
de Almeida CMO, Brito MMC, Bosaipo NB, Pimentel AV, Sobreira-Neto MA, Tumas V, Zuardi AW, Crippa JAS, Hallak JEC, Eckeli AL
DOI 10.1089/can.2021.0158↗
Design: RCT
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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.
Indication
Further studies on Parkinson Disease
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A Peball et al. · 2020 · Annals of neurology
118 citations
Non-Motor Symptoms in Parkinson's Disease are Reduced by Nabilone.
Mixed RCT

Phase-II-RCT, n=47 Parkinson-Patienten mit stabiler Motorik aber störenden Non-Motor-Symptoms (NMS, MDS-UPDRS-I ≥4). Open-label Nabilone-Titration (0,25–1 mg 2×/d), dann Randomisierung Responder zu Nabilone vs. Placebo (n=19). Primärer Endpunkt MDS-UPDRS-I nach 4 Wochen: Placebo-Gruppe verschlechterte sich um 2,63 Punkte (95% CI 1,53–3,74, p=0,002), Nabilone-Gruppe nur um 1,00 Punkte (95% CI −0,16–2,16, p=0,280); Differenz 1,63 Punkte (95% CI 0,09–3,18, p=0,030, Effektgröße 0,66). Positive Effekte v.a. auf Angst und nächtliche Schlafprobleme. 77% AEs in Titrationsphase (meist transient), keine schwerwiegenden AEs.

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The impediment to action advances action. — Marcus Aurelius