临床试验/NCT00311363

NCT00311363已完成3 期

A Long-Term Study of XP13512 Versus Placebo Treatment Assessing Maintenance of Efficacy and Safety in Patients With Restless Legs Syndrome.

XenoPort, Inc.0 个研究点目标入组 327 人开始时间: 2006年4月最近更新: 2013年7月22日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: XenoPort, Inc.
入组人数: 327
主要终点: Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period

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记录与标识符相似试验

研究概览

简要总结

The primary objective of this trial is to assess the maintenance of efficacy of gabapentin enacarbil (GEn, XP13512) taken once daily in the long-term treatment of patients suffering from Restless Legs Syndrome (RLS).

详细描述

This study was a multicenter, blinded, randomized withdrawal study in subjects with primary Restless Legs Syndrome (RLS). Eligible subjects were initially enrolled in a 24-week single blind (SB) treatment period during which they received XP13512. Subjects who completed the initial treatment period and met the responder criteria were then randomized 1:1 to receive either XP13512 or placebo during the 12-week double-blind (DB) treatment period. The primary study objective was to assess the maintenance of efficacy of XP13512 1200 mg taken once daily in the long-term treatment of subjects with primary RLS. The secondary study objectives were to assess maintenance of improvements in sleep outcomes and quality of life, and to assess the safety and tolerability of XP13512 in the treatment of primary RLS subjects.

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

•Patients with primary RLS, based on the International RLS Study Group Diagnostic Criteria.

排除标准

•A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS;
•Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's disease, Multiple Sclerosis, dyskinesias, and dystonias);
•Abnormal laboratory results, electrocardiogram (ECG) or physical findings;
•Pregnant or lactating women;
•Women of childbearing potential who are not practicing an acceptable method of birth control.

研究组 & 干预措施

GEn (XP13512) 1200 mg

Experimental

GEn (XP13512) 1200 mg

干预措施: GEn (XP13512) (Drug)

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period

时间窗: DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)

Relapse was defined as worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week double-blind (DB) treatment period (the period from Randomization on Visit 14 \[Week 24\] through the end of treatment). Worsening of symptoms was defined as an increase in the total International RLS (IRLS) Scale score by at least 6 or more points relative to the participant's score at Randomization, achieving an IRLS score of at least 15, and an assessment of "much worse" or "very much worse" on the investigator-rated Clinical Global Impression of Change (CGI-C).

次要结局

Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period(DB Treatment Period; Days 169 to 252 (Weeks 24 to 36))
Time From Randomization to Relapse in RLS Symptoms During the Double-Blind Treatment Period (Excluding First Two Weeks of DB Phase)(DB Treatment Period; Days 184 to 252 (Weeks 26 to 36))
Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF)(Randomization (Week 24) and Week 36 (or end of DB treatment))
Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF(Randomization (Week 24) and Week 36 (or end of DB treatment))
Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF(Randomization (Week 24) and Week 36 (or end of DB treatment))
Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF(Week 36 (or end of DB treatment))
Percentage of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Week 36 (DB Treatment Phase) Using LOCF(Week 36 (or end of DB treatment))
Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF(Randomization (Week 24) and Week 36 (or end of DB treatment))
Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF(Randomization (Week 24) and Week 36 (or end of DB treatment))
Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF(Randomization (Week 24) and Week 36 (or end of DB treatment))
Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF(Randomization (Week 24) and Week 36 (or end of DB treatment))
Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score(Randomization (Week 24) and Week 36 (or end of DB treatment))
Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase)(Week 36 (or end of DB treatment))
Median Time to Onset of First RLS Symptoms Using the 24-hour RLS Symptom Record at Week 36 (DB Treatment Phase)(Week 36 (or end of DB treatment))
Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF(Randomization (Week 24) and Week 36 (or end of DB treatment))
Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF(Randomization (Week 24) and Week 36 (or end of DB treatment))
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF(Randomization (Week 24) and Week 36 (or end of DB treatment))
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF(Randomization (Week 24) and Week 36 (or end of DB treatment))
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF(Randomization (Week 24) and Week 36 (or end of DB treatment))
Mean Change From Baseline in the IRLS Scale Total Score at Week 24 (SB Treatment Phase) Using LOCF(Days 1 to 168 (Baseline to Week 24 of SB Phase))
Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF(Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase)
Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF(Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase)
Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF(Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase)
Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF(Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase)
Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF(Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase)
Mean Change From Baseline in the MOS Sleep Scale Domain, Sleep Quantity, Score at Week 24 (SB Treatment Period) Using LOCF(Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase)
Mean Change From Baseline in the Overall Quality of Life Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 24 (SB Treatment Phase)(Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase)
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF(Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase)
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF(Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase)
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF(Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase)
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF(Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase)
Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF(Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase)

研究者

发起方

XenoPort, Inc.

申办方类型

Industry

责任方

Sponsor

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