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
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Efficacy of d-methadone
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary RLS.
- •Moderate to very severe RLS defined as IRLS-RS score >
- •Written informed consent.
- •Willingness and ability to participate in the trial
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 ≥
- •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.
研究组 & 干预措施
25 mg d-methadone
The experimental drug is a tablet formulation of d-methadone HCl in dose strength of 25 mg.
干预措施: D-methadone (Drug)
Placebo
The placebo is an exact match to the active tablets in size, color and marking without the active ingredient d-methadone HCl.
干预措施: Placebo (Other)
结局指标
主要结局
Efficacy of d-methadone
时间窗: 30 days
The percentage of responders to d-methadone treatment. A responder is defined as patient who has ≥ 50% reduction in the International RLS Rating Scale (IRLS-RS) score from baseline to end of the 30-day treatment period.
次要结局
- Insomnia severity(10 and 30 days)
- Periodic limb movements of sleep index(10 days)
- Change in Quality of life(10 and 30 days)
- Actigrafic parameters(10 and 30 days)
研究者
Mauro Manconi
Prof. MD
Ente Ospedaliero Cantonale, Bellinzona