NCT04145674

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

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mauro Manconi · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	D-methadone	Patients will take one tablet of 25 mg d-methadone once daily at 6 pm over a period of 30 days
OTHER	Placebo	Patients will take one tablet of placebo once daily at 6 pm over a period of 30 days

Timeline

• Start date: 2022-10-22
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2019-10-30
• Last updated: 2026-03-13

Locations

4 sites across 2 countries: Italy, Switzerland