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

NCT04145674 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Clinical Trial Unit Ente Ospedaliero Cantonale

    collaborator OTHER

  • Mauro Manconi

    lead OTHER

Principal Investigators

  • Mauro Manconi, Prof. MD · Ente Ospedaliero Cantonale, Neurocenter of Southern Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-22
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • Italy
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04145674 on ClinicalTrials.gov