NCT01061372撤回3 期
Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment
研究概览
简要总结
The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate to severe Restless Legs Syndrome in comparison to placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Restless Legs Syndrome with the presence of all four clinical manifestations of RLS:
- •RLS symptoms occur predominantly in the evening
- •RLS history at least 6 months
- •International Restless Legs Study Group Rating Scale (IRLS) greater than or equal to 15 at the beginning and the end of placebo run-in
- •Have greater than or equal to 15 nights with RLS symptoms in the month prior to screening
排除标准
- •Any secondary RLS
- •Current augmentation due to RLS treatment
- •Placebo responders identified during the placebo run-in
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Pregabalin 150 mg/day
Experimental
干预措施: pregabalin (Drug)
Pregabalin 300 mg/day
Experimental
干预措施: pregabalin (Drug)
结局指标
主要结局
The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment
时间窗: up to 12 weeks
Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment
时间窗: up to 12 weeks
次要结局
- Impact on Life (IRLS symptom impact sub-score)(up to 12 weeks)
- Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide(up to 12 weeks)
- Subjective Sleep Questionnaire (SSQ - Subjective WASO)(up to 12 weeks)
- RLS Next Day Impact (RLS-NDI)(up to 12 weeks)
- Medical Outcomes Study - Sleep Scale (MOS - SS)(up to 12 weeks)
- Clinical Global Impressions - Severity (CGI-S)(up to 12 weeks)
- Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group(up to 12 weeks)
- Changes in RLS symptoms following the discontinuation of study drug at the end of treatment will be evaluated by collection of the IRLS scores at the end of the drug taper period at Week 13(week 13)
- Limb pain rating using a numerical rating scale (Limb Pain - NRS)(up to 12 weeks)
- Medical Outcomes Study - Short Form 36 (SF-36)(up to 12 weeks)
- Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP)(up to 12 weeks)
- Profile of Mood States (POMS)(up to 12 weeks)
- RLS-Quality of Life Scale (RLS-QoL)(up to 12 weeks)
研究者
相似试验
已完成
3 期
Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome PatientsIdiopathic Restless Legs SyndromeNCT00806026Pfizer's Upjohn has merged with Mylan to form Viatris Inc.731
已完成
3 期
A Study of the Efficacy and Safety of Pregabalin for the Treatment of FibromyalgiaFibromyalgiaNCT00645398Pfizer's Upjohn has merged with Mylan to form Viatris Inc.751
已完成
3 期
A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic PainNeuropathic PainNCT00301223Pfizer's Upjohn has merged with Mylan to form Viatris Inc.309
已完成
3 期
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.Generalized Tonic Clonic SeizuresNCT01747915Pfizer's Upjohn has merged with Mylan to form Viatris Inc.219
已完成
3 期
A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic NeuralgiaNeuralgia, PostherpeticNCT00394901Pfizer's Upjohn has merged with Mylan to form Viatris Inc.372