NCT01332318已完成2 期
A Randomized, Double Blind, Active- and Placebo-Controlled, Parallel Group Safety Study Assessing Simulated Driving Performance in XP13512-(GSK1838262) Treated Patients With Restless Legs Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax)
研究概览
简要总结
This study was a multi center, randomized, double blind, active and placebo controlled, parallel group study to assess simulated driving performance in XP13512 treated subjects with Restless Legs Syndrome (RLS). Eligible subjects were randomized to receive a once daily dose of placebo (2 groups), XP13512 1200 mg, or XP13512 1800 mg for 16 days. On Day 16, one of the placebo groups also received one 50 mg dose of diphenhydramine (DPH) to assess the effects of an agent known to have sedative properties, while the other 3 groups received a DPH placebo.
详细描述
This study was a multicenter, randomized, double blind, active and placebo controlled, parallel group study. Eligible subjects were randomized in a 1:1:1:1 ratio to 1 of the following 4 treatment groups:
A) XP13512 Placebo + Diphenhydramine Placebo (Pbo) B) XP13512 1200 mg/day + Diphenhydramine Placebo (1200 mg) C) XP13512 1800 mg/day + Diphenhydramine Placebo (1800 mg) D) XP13512 Placebo + 50 mg Diphenhydramine (Pbo/DPH)
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women who were 21 through 65 years of age and fluent in English;
- •Subjects with RLS, based on the IRLSSG Diagnostic Criteria;
- •Currently a licensed and experienced driver who has driven an average of 3 or more times/week for the past 3 years;
- •Able to successfully complete the 5 minute practice simulated driving test at Screening;
- •History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started;
- •Total RLS severity score of 15 or greater on the IRLS Rating Scale;
- •Documented RLS symptoms for at least 4 of the 7 consecutive evenings/nights Discontinuation of treatments for RLS (e.g., opioids, benzodiazepines, dopamine agonists and/or gabapentin) at least 2 weeks prior to Screening; -
- •Body Mass Index of 34 or below;
- •Estimated creatinine clearance of at least 60 mL/min;
- •Agreed to maintain abstinence from alcohol and smoking throughout the entire study period;
- •Agreed to maintain abstinence from caffeine from midnight of the day prior to and until the end of each Visit (Visits 2 to 4).
排除标准
- •A sleep disorder (e.g., sleep apnea) other than RLS that may significantly affect the assessment of RLS;
- •Current use of a sleeping medication or sedating medication;
- •Current use of CNS stimulants;
- •Neurologic disease or movement disorder;
- •Other medical conditions which could affect RLS assessments;
- •Significant medical history that may impair psychomotor coordination;
- •Subjects who had clinically significant or unstable medical conditions;
- •Serum ferritin level below 20 ng/mL;
- •Subjects currently suffering from moderate or severe depression using the Diagnostic and Statistical Manual of Mental Disorders and Treatment IV (DSM IV TR);
- •Subjects with a history of substance abuse (alcohol or drugs) or substance dependence within 12 months prior to enrollment;
- •Shift workers or subjects who were not on normal day/night sleep cycles;
- •Subjects who had smoked an average of greater than one half pack of cigarettes (or nicotine equivalent) per day within 30 days of the Screening Visit;
- •Subjects who had consumed an average of >5 cups (i.e., 40 ounces) of caffeinated beverages per day within 20 days of the Screening Visit;
- •Subjects with a history of allergy to gabapentin, diphenhydramine, or XP13512 excipients
研究组 & 干预措施
Placebo
Placebo Comparator
XP13512 Placebo + Diphenhydramine Placebo
干预措施: Placebo (Drug)
XP13512 1200 mg
Experimental
XP13512 1200 mg/day + Diphenhydramine Placebo
干预措施: XP13512 (Drug)
XP13512 1800 mg
Experimental
XP13512 1800 mg/day + Diphenhydramine Placebo
干预措施: XP13512 (Drug)
Placebo + Diphenhydramine
Active Comparator
XP13512 Placebo + 50 mg Diphenhydramine
干预措施: Diphenhydramine (Drug)
Placebo + Diphenhydramine
Active Comparator
XP13512 Placebo + 50 mg Diphenhydramine
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax)
时间窗: Baseline (Day -1) and Day 16
Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 16 mean LPV over the 1-hour drive minus the Baseline mean LPV over the 1-hour drive. The Day 16 measurement is at the time of maximum concentration (Tmax) for both GEn and DPH.
次要结局
- Change From Baseline (Day -1) to Day 14 (Evening) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Lane Position Variability (LPV)(Baseline (Days -1 and 1) and Days 14 and 15)
- Number of Participants With the Indicated Number of Simulated Crashes on Days 14 (Evening), 15 (Morning After Dose), and 16 (Tmax)(Days 14, 15, and 16)
- Mean Change From Baseline (Day -1) at Day 14 in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score(Baseline (Day -1) and Day 14)
- Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Digit Sequencing Score (DSS)(Baseline (Days -1and 1) and Days 14, 15, and 16)
- Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Token Motor Task Test Score(Baseline (Days -1and 1) and Days 14, 15, and 16)
- Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Fluency Test Score(Baseline (Days -1 and 1) and Days 14, 15, and 16)
- Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Symbol Coding Test Score(Baseline (Days -1and 1) and Days 14, 15, and 16)
- Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Tower of London (TOL) Score(Baseline (Days -1and 1) and Days 14, 15, and 16)
- Number of Participants in Each Category of the Investigator-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14(Day 14)
- Number of Participants in Each Category of the Participant-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14(Day 14)
- Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Lane Position(Baseline (Days -1 and 1) and Days 14, 15, and 16)
- Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Speed Variability(Baseline (Day -1) and Days 14 and 16; baseline (Day 1) and Day 15)
- Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Speed(Baseline (Days -1 and 1) and Days 14, 15, and 16)
- Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Alertness Visual Analog Scale (VAS) Score(Baseline (Days -1 and 1) and Days 14, 15, and 16)
- Change From Baseline (Day -1) to Day 14 (Evening) in the Epworth Sleepiness Scale (ESS) Total Score(Baseline (Day -1) and Day 14)
- Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Composite Score(Baseline (Days -1 and 1) and Days 14, 15, and 16)
- Number of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated CGI-I at Day 14(Day 14)
- Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Brake Reaction Time(Baseline (Days -1 and 1) and Days 14, 15, and 16)
- Number of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Day 14(Day 14)
- Median Time to Onset of a Participant's First RLS Symptoms Using the 24-hour RLS Symptom Record at Day 14(Day 14)
- Percentage of Participants With no Reported RLS Symptoms During the 24-hour RLS Record at Day 14(Day 14)
- Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Day 14(Day 14)
- Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Memory Test Score(Baseline (Days -1and 1) and Days 14, 15, and 16)
- Number of Participants With the Indicated Post Sleep Questionnaire (PSQ) Responses at Day 14(Day 14)
- Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Pittsburgh Sleep Diary (PghSD) Sleep Onset Items(Baseline (Days -1and 1) and Days 14, 15, and 16)
- Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Total Sleep Time Item(Baseline (Days -1 and 1) and Days 14, 15, and 16)
- Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Sleep Quality(Baseline (Day -1and 1) and Days 14, 15, and 16)
研究者
研究点 (1)
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