A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo
Reason given: budget issues
Key facts
- Phase
- Phase 2
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
Trial details
- Who runs it
- Mauro Manconi
- Trial code
- NCT04145674EU 2024-510968-22-00
- Record updated
- 13 March 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Any other concomitant treatment for RLS (wash-out period: at least 7 days); Concomitant use of psycho-drugs dopamine agonists and opioids (wash-out period: at least 7 days); Previous enrolment into the current study; Participation in another study with investigational drug within the 30 days preceding and during the present study; Positive history of known causes of secondary RLS; Evidence of clinically significant hepatic or renal impairment; 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; Inability to follow the procedures of the study, (e.g. due to language problems, psychological disorders, dementia, etc. of the participant); 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; 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; Women who are pregnant or breast feeding; Enrolment of the investigator, his/her family members, employees and other dependent persons.