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

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.

Timeline

Start

2022-10-22

Primary completion

2026-12-30

Completion

2026-12-30

Outcome

Outcome not reported

Stopped: “budget issues”

Drugs

Indications