An Open-Label, 52-Week Extension Study Assessing XP13512 Safety and Efficacy in Patients With Restless Legs Syndrome.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 581
- 主要终点
- Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC)
研究概览
简要总结
The primary objective of this trial is to assess the long-term safety and efficacy of XP13512 (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless Legs Syndrome (RLS).
详细描述
Study XP055 is a multicenter, open-label, 52-week extension study of XP13512 (Gabapentin Enacarbil [GEn]) given once daily to eligible subjects with Restless Legs Syndrome (RLS) who had previously completed 1 of the following studies and met eligibility criteria: XP052 (110963 [NCT00298623]), XP053 (111460 [NCT00365352]), XP081 (111462 [NCT01332305]), and XP083 (111463 [NCT01332318]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 who have successfully completed one of the following studies: XP052 (110963 [NCT00298623]), XP053 (111460 [NCT00365352]), XP081 (111462 [NCT01332305]), and XP083 (111463 [NCT01332318]).
排除标准
- •Subjects who, in the opinion of the Investigator, would be non-compliant with the study visit schedule, procedures, or medication administration.
研究组 & 干预措施
XP13512 (GEn)
1200 mg XP13512, orally, once daily for 52 weeks
干预措施: XP13512 (GEn) (Drug)
结局指标
主要结局
Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC)
时间窗: Baseline and Week 52
The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the Week 52 value minus the baseline value. Change scores with higher value represents greater improvement in RLS symptoms.
Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC
时间窗: Weeks 0, 1, 4, 12, 24, 36, and 52
The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being "very much improved" and a score of 7 being "very much worse" compared to the start of the study. Responders on the CGI-I are defined as those with a score of 1 or 2, corresponding to "very much improved" or "improved," respectively.
次要结局
- Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC(Weeks 0, 1, 4, 12, 24, and 36)
- Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC(Weeks 0, 1, and 52)
- Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC(Weeks 0, 1, 4, 12, 24, 36, and 52)
- Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC(Weeks 0, 1, and 52)
- Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data(Week 52)
- Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52(Weeks 24 and 52)
- Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52(Weeks 24 and 52)
- Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores(Baseline and Weeks 24 and 52)
- Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked(Baseline and Weeks 24 and 52)
- Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity(Baseline and Weeks 24 and 52)