CTIS2024-510968-22-00招募中1 期
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 - NSI-RLS-001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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
排除标准
- •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).
研究者
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