BridgeMD
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
EU CTIS ID: 2024-510968-22-00
What this study is testing
to investigate the efficacy of 30 days of daily dosing with 25 mg REL-1017 compared to placebo in patients with primary, moderate to very severe RLS.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female aged between 18 and 75 years old, inclusive
- Diagnosis of primary RLS.
- Moderate to very severe RLS defined as IRLS-RS score > 10
You likely can't join if
- 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
- Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 x upper limit of normal (ULN) total bilirubin > 1 x ULN creatinine > 1 x ULN
- 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.
See the full eligibility criteria
- Male and female aged between 18 and 75 years old, inclusive
- Diagnosis of primary RLS.
- Moderate to very severe RLS defined as IRLS-RS score > 10
- 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
- Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 x upper limit of normal (ULN) total bilirubin > 1 x ULN creatinine > 1 x ULN
- 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 (e.g., benzodiazepines, antidepressants), dopamine agonists and opioids (wash-out period: at least 7 days)
- History of allergy or hypersensitivity to methadone or related drugs (e.g., opioids).
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.