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

Phase 1

Recruiting

• Conditions: restless leg syndrome; MedDRA version: 21.1Level: PTClassification code: 10058920Term: Restless legs syndrome Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2024-510968-22-00
• Lead Sponsor: Ente Ospedaliero Cantonale (EOC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion 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

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, 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified