Testing d-Methadone for treating Restless Legs Syndrome
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
This study is testing if a new medication called d-methadone can help people with moderate to very severe Restless Legs Syndrome feel better and sleep more soundly.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 4 sites (Milan and 3 other locations) |
| Trial ID | NCT04145674 on ClinicalTrials.gov |
What this trial studies
This is a proof of concept, double-blind, randomized trial evaluating the efficacy of d-methadone in patients diagnosed with primary, moderate to very severe Restless Legs Syndrome (RLS). Participants will receive either the study drug or a placebo once daily for 30 consecutive days. The trial aims to assess the impact of d-methadone on RLS symptoms, particularly focusing on its potential to improve sleep disturbances and overall quality of life. The study is designed to provide initial evidence for the glutamatergic mechanism of action of d-methadone in treating RLS.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with primary Restless Legs Syndrome who have moderate to very severe symptoms.
Not a fit: Patients with secondary causes of Restless Legs Syndrome or those currently on other RLS treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from severe Restless Legs Syndrome.
How similar studies have performed: While this approach is novel for d-methadone in RLS treatment, similar studies have explored glutamatergic mechanisms in other conditions with varying success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Positive history of known causes of secondary RLS. * Any other concomitant treatment for RLS (wash-out period: at least 7 days). * Moderate-severe sleep apnea defined as Apnea Hypopnea Index ≥ 15. * History or presence of clinically significant abnormality as assessed by neurological examination which in the opinion of the Investigator would jeopardize the safety of the patients or the validity of the study results. * Evidence of clinically significant hepatic or renal impairment * History or family history of sudden unexplained death or long QT syndrome. * Any 12-lead ECG with demonstration of QTc ≥ 450 msec or a QRS interval ≥ 120 msec at Screening. * Concomitant use of psycho-drugs dopamine agonists and opioids (wash-out period: at least 7 days). * History or presence of any condition in which an opioid is contraindicated * History of allergy or hypersensitivity to methadone or related drugs. * Any clinically significant neurological, sleep, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, chronic pain, psychiatric or gastrointestinal disorder. * Women who are pregnant or breast feeding. * Inability to follow the procedures of the study, (e.g. due to language problems, psychological disorders, dementia, etc. of the participant). * Previous enrolment into the current study. * Enrolment of the investigator, his/her family members, employees and other dependent persons. * Participation in another study with investigational drug within the 30 days preceding and during the present study.
Where this trial is running
Milan and 3 other locations
- Sleep Center, IRCCS San Raffaele — Milan, Italy (Recruiting)
- Schlaf-Wach-Epilepsie Zentrum, Inselspital — Bern, Switzerland (Recruiting)
- Neurologie / Schlaflabor Kantonsspital Graubünden — Chur, Switzerland (Recruiting)
- Sleep Center, Neurocenter of Southern Switzerland — Lugano, Switzerland (Recruiting)
Study contacts
- Principal investigator: Mauro Manconi, Prof. MD — Ente Ospedaliero Cantonale, Neurocenter of Southern Switzerland
- Study coordinator: Mauro Manconi, Prof. MD
- Email: mauro.manconi@eoc.ch
- Phone: +41 91 811 68 25
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.