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临床试验/NCT00991276
NCT00991276已完成3 期

A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover, Multicenter Polysomnography Study Of Pregabalin And Pramipexole In Adults With Restless Legs Syndrome

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2009年12月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
85
试验地点
1
主要终点
Wake After Sleep Onset (WASO)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • •Diagnosis of restless legs syndrome with a total score of 15 or more points on the International RLS rating scale (IRLS).
  • •RLS symptoms interfering with sleep on 3 or more nights per week for at least 6 months.
  • •PSG confirmation of WASO of at least 60 min, PLMI of 10 or more, and total sleep time of at least 3 hrs and less than 6.5 hrs.

排除标准

  • •Secondary RLS.
  • •Daytime RLS symptoms requiring treatment.
  • •Primary sleep disorder.
  • •Sleep apnea.
  • •Night or shift work.
  • •Concurrent medical disorder that could interfere with efficacy assessment or present a safety concern.
  • •Pregnant or lactating women.
  • •Women of child-bearing potential not using acceptable method of birth control.
  • •Use of prohibited medication.

研究组 & 干预措施

pregabalin

Experimental

干预措施: pregabalin (Drug)

placebo

Placebo Comparator

干预措施: placebo (Drug)

pramipexole

Active Comparator

干预措施: pramipexole (Drug)

结局指标

主要结局

Wake After Sleep Onset (WASO)

时间窗: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET)

WASO as determined by Polysomnography (PSG) was time spent awake from sleep onset to final awakening. WASO= Wake Time During Sleep \[WTDS\] epochs + Wake Time After Sleep \[WTAS\] epochs)/2. WTDS: number of wake epochs (30 seconds of PSG recording) after onset of persistent sleep and prior to final awakening or end of 8-hour recording/2 and WTAS: number of wake epochs after final awakening until end of the 8-hour recording/2. WASO was measured on 2 consecutive days within a period. Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model.

次要结局

  • Subjective Total Sleep Time (sTST)(Week 3 and Week 5 of Each Intervention Period or ET)
  • Periodic Limb Movement Arousal Index (PLMAI)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Periodic Limb Movement Index (PLMI)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Minutes of Stage N1, N2, N3 and R Sleep(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Number of Arousals (NASO)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Restless Legs Syndrome-Next Day Impact (RLS-NDI)(Week 3 and Week 5 of Each Intervention Period or ET)
  • Periodic Limb Movement in Sleep Index (PLMSI)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Arousal Index (NASOI)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • International Restless Legs Syndrome Study Group Rating Scale (IRLS)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) Scale(Baseline, Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Latency to Stage R Sleep (LREM)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Latency to Persistent Sleep (LPS)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Wake Time During Sleep (WTDS)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Wake Time After Sleep (WTAS)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Total Sleep Time (TST)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Sleep Efficiency (SE)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Hourly and Quarterly Assessment of Wake After Sleep Onset (WASO)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Hourly and Quarterly Assessment of Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Hourly and Quarterly Assessment of Number of Awakenings of at Least 2 Epoch After Sleep Onset (NAASO2)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Hourly and Quarterly Assessment of Number of Arousals (NASO)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Hourly and Quarterly Assessment of Periodic Limb Movement (PLM)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Hourly and Quarterly Assessment of Sleep Efficiency (SE)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale(Week 3 and Week 5 of Each Intervention Period or ET)
  • Subjective Sleep Questionnaire (SSQ): Total Wake Time After Sleep Onset Subscale(Week 3 and Week 5 of each intervention period or ET)
  • Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale(Week 3 and Week 5 of each intervention period or ET)
  • Subjective Sleep Questionnaire (SSQ): Latency Subscale(Week 3 and Week 5 of each intervention period or ET)
  • Medical Outcomes Study - Sleep Scale (MOS-SS)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)
  • Restless Leg Syndrome - Quality of Life Scale (RLS-QoL)(Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET)

研究者

发起方
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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