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A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo — Glu-REST  

Restless Legs Syndrome Clinical Trial

Official title:
A Proof of Concept, Multicentre, Phase 2, Double-Blind, Randomized, Placebo-Controlled Study on the Efficacy, Safety and Tolerability of d-Methadone in Moderate to Very Severe Restless Legs Syndrome With Periodic Limb Movements: the Glu-REST Study

Clinical Trial Summary

Proof of concept, double-blind, randomized, placebo-controlled trial with d-methadone proposed for the first time for use in the treatment of patients diagnosed with primary, moderate to very severe Restless Legs Syndrome (RLS). Its glutamatergic mechanism of action might be effective on RLS arousal pattern and sleep disturbance which highly impair the quality of life of RLS's patients. Patients will take the study drug/placebo once a day for 30 consecutive days.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04145674
Study type Interventional
Source Ente Ospedaliero Cantonale, Bellinzona
Contact Mauro Manconi, Prof. MD
Phone +41 91 811 68 25
Email mauro.manconi@eoc.ch
Status Recruiting
Phase Phase 2
Start date October 22, 2022
Completion date July 30, 2025
View Details
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