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
Who is this study for? Patients with moderate to very severe restless legs syndrome with periodic limb movements
What treatments are being studied? D-methadone
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Diagnosis of primary RLS.
• Moderate to very severe RLS defined as IRLS-RS score \> 10.
• Written informed consent.
• Willingness and ability to participate in the trial
Locations
Other Locations
Italy
Sleep Center, IRCCS San Raffaele
RECRUITING
Milan
Switzerland
Schlaf-Wach-Epilepsie Zentrum, Inselspital
RECRUITING
Bern
Neurologie / Schlaflabor Kantonsspital Graubünden
RECRUITING
Chur
Sleep Center, Neurocenter of Southern Switzerland
RECRUITING
Lugano
Contact Information
Primary
Mauro Manconi, Prof. MD
mauro.manconi@eoc.ch
+41 91 811 68 25
Backup
Jane Frangi
JaneMarit.Frangi-Kultalahti@eoc.ch
+41 91 811 6050
Time Frame
Start Date: 2022-10-22
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 50
Treatments
Experimental: 25 mg d-methadone
The experimental drug is a tablet formulation of d-methadone HCl in dose strength of 25 mg.
Placebo_comparator: Placebo
The placebo is an exact match to the active tablets in size, color and marking without the active ingredient d-methadone HCl.
Related Therapeutic Areas
Sponsors
Collaborators: Clinical Trial Unit Ente Ospedaliero Cantonale
Leads: Mauro Manconi