A Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess Efficacy and Safety of Pregabalin in Willis-Ekbom Disease/Restless Legs Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- International restless legs scale score
研究概览
简要总结
This randomized, double-blind, placebo-controlled, multicenter clinical trial is designed to to assess the treatment efficacy and tolerability of pregabalin in patients with idiopathic restless legs syndrome in South Korea.
详细描述
Objectives: To assess the treatment efficacy and tolerability of pregabalin in patients with idiopathic restless legs syndrome (RLS) in South Korea.
Study Design: A randomized, double-blind, placebo-controlled, multicenter clinical trial Study period: total 14 weeks: 2 weeks for placebo run in period and 12 weeks treatment after randomization (titration for 4 weeks and maintenance for 8 weeks).
Subjects: a total number of 100 participants (randomly assigned 1:1 to pregabalin or placebo). The sample number was calculated based on a superiority design, 1-sided, alpha 0.05 with power 80% and drop rate 10%.
Inclusion criteria: adults aged between 19-80 and diagnosed with idiopathic RLS with IRLS score of 15 or more.
Exclusion criteria: Secondary RLS; serum ferritin < 10 μg/L or history of oral iron therapy within 3 months or intravenous iron therapy within 1 year; severe comorbid medical or psychiatric disorders; history of pregabalin or gabapentin treatment within 3 months; other comorbid sleep disorders or shift workers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IRLS (international restless legs scale) score ≥ 15
- •RLS symptom occurring ≥ 3 times/week and persisting over ≥ 6 months
- •Drug-naive patients or those who stop taking RLS drugs for ≥ 1 week before screening
排除标准
- •Secondary RLS (including iron deficiency anemia, pregnancy, chronic kidney disease [eGFR < 60 mL/min/1.73 m2], peripheral neuropathy, others)
- •Serum Ferritin < 10 μg/L or history of oral iron therapy within 3 months or intravenous iron therapy within 1 year
- •Severe comorbid medical or psychiatric disorders
- •history of pregabalin or gabapentin treatment within 3 months
- •High risk of obstructive sleep apnea by STOP-BANG questionnaire
- •Other comorbid sleep disorders or shift workers
- •Hypersensitivity to pregabalin
- •Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
研究组 & 干预措施
Placebo
干预措施: Placebos (Drug)
Pregabalin
干预措施: Pregabalin 75mg (Drug)
结局指标
主要结局
International restless legs scale score
时间窗: Baseline (week 0) and post-treatment (week 12)
Changes in International restless legs scale (IRLS) score after 12-week treatment. IRLS is used to assess the severity of patient's RLS symptoms. A total score ranges from 0 to 40 and higher scores mean more severe symptoms. Therefore, greater differences in IRLS scores between baseline and post-treatment mean a better outcome.
次要结局
- Restless legs syndrome (RLS)-6(Baseline (week 0) and post-treatment (week 12))
- Johns Hopkins Restless legs syndrome quality of life(Baseline (week 0) and post-treatment (week 12))
- Remission rate(Baseline (week 0) and post-treatment (week 12))
- PSQI (pittsburgh sleep quality index)(Baseline (week 0) and post-treatment (week 12))
- 10-cm visual analog scale (VAS)(Baseline (week 0) and post-treatment (week 12))
- ISI (insomnia severity index)(Baseline (week 0) and post-treatment (week 12))
- CGI (clinical global impression)-improvement(Post-treatment (week 12))
研究者
Ki-Young Jung
Professor
Seoul National University Hospital