Study RXP110908, a Polysomnography Study of GSK1838262 (XP13512) Extended Release Tablets Versus Placebo in the Treatment of Restless Legs Syndrome (RLS) and Associated Sleep Disturbance
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.
详细描述
Double-blind, multi-center, placebo-controlled, 2-period crossover study which assessed the efficacy and safety of gabapentin enacarbil (GEn; GSK1838262; XP13512) extended release tablets in adults with Restless Legs Syndrome (RLS)-associated sleep disturbance. One hundred thirty-six (136) adult subjects with RLS-associated sleep disturbance and periodic limb movements (PLM) were randomized from 23 centers in the United States. Subjects who met all eligibility criteria were randomized to receive a treatment sequence of GEn:placebo or placebo:GEn. Investigational product was taken with food at approximately 5pm. Investigational product was dosed as 600mg/day x3 days followed by 1200mg/day x25 days for each 4-week treatment period. There was a 1-week taper at 600mg after each treatment period followed by a 1-week washout between treatments. Polysomnography (PSG) was used to objectively evaluate changes in sleep and PLMs.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GSK1838262:placebo
GSK1838262 extended release tablets for Treatment Period 1 followed by Placebo for Treatment Period 2
干预措施: Placebo (Drug)
Placebo:GSK1838262
Placebo for Treatment Period 1 followed by GSK1838262 for Treatment Period 2
干预措施: GSK1838262 Extended Release Tablets (Drug)
结局指标
主要结局
Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF)
时间窗: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)
PSG is a comprehensive recording of the bio-physiological changes that occur during sleep. It is also known as a "sleep study" that monitors participants as they sleep or try to sleep. WTDS, defined as the total amount of time spent awake after falling asleep until the last awakening, was measured by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects.
次要结局
- Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in Time Spent in the REM (Rapid Eye Movement) Sleep Stage at Week 4/10 as Measured by Polysomnography Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Number of PLMAI Responders at Week 4/10 Using LOCF(Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in Participant's Ratings of Feeling Rested Upon Awakening as Measured by the Subjective Post Sleep Diary (SPSD) at Week 4/10 Using LOCF.(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the Self-reported Number of Hours Spent Awake During the Night (SPSD) Due to RLS at Week 4/10 Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF(Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the Sleep Efficiency Measured by Polysomnography (PSG) at Week 4/10 Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the Wake After Sleep Onset (WASO) Measured by Polysomnography (PSG) at Week 4/10 Using LOCF.(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the Suggested Immobilization Test (SIT) PLM Index at Week 4/10(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the SIT MDS (Mean Leg Discomfort Score), Mean of Scores From 0 to 60 Minutes, at Week 4/10(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Number of Participants Who Responded Affirmatively to Each of the 4 Items of the Participant-completed Patient Global Impression of Therapy at Week 4/10 Using LOCF(Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Adjusted Mean Change From Baseline in the Clinical Global Impression of Illness - Severity (CGI-S) Score at Week 4/10 Using LOCF(Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale "Responders" at Week 4/10 Using LOCF(Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))
- Number of Participants Who Self-reported "Very Satisfied" or "Satisfied" With the Investigational Product at Week 4/10 Using LOCF(Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10))