A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study of the Safety and Efficacy of LY2624803 in Outpatients With Insomnia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 643
- 试验地点
- 1
- 主要终点
- Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint
研究概览
简要总结
The purpose of this study is to compare an investigational drug (LY2624803) with placebo and with zolpidem in the treatment of outpatients with chronic insomnia.
详细描述
Outpatients with chronic insomnia who participate in this study will be treated in each of four 2-week treatment periods with bedtime doses of either placebo, zolpidem, LY2624803 1 mg, or LY2624803 3 mg. Neither patients nor investigators will be told what treatments are being given in any treatment period. A patient who completes all four treatment periods will be treated with placebo in 1, 2, or 3 of the periods; with zolpidem in 0, 1, or 2 of the periods; and with LY2624803 in either 1 or 2 of the periods. No patient will receive placebo for all four of the 2-week treatment periods. All patients will receive LY2624803 for at least one of the four 2-week treatment periods. During each treatment period, patients will record information each morning about their sleep the night before, and each evening about their functioning since waking up. Patients will also wear wrist actigraphy devices to record their physical activity. At the conclusion of each treatment period, patients will answer questions about their sleep, functioning, health, and relative preference for treatments.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be between 18 and 85 years of age, with a stable living situation
- •Clinical diagnosis of either primary insomnia or "secondary" insomnia (comorbid with depression, anxiety, and/or medical illness)
- •Insomnia systems must be at least moderate in severity within the month prior to study entry, and must include difficulty staying asleep and/or problems with awakening earlier than desired
- •Psychiatric and medical conditions present must be stable over the 3 months prior to study entry, and not expected to worsen significantly or require hospitalization during participation in the study
- •Ongoing treatments for psychiatric and medical conditions present must have been stable for the 3 months prior to study entry, and must be expected to remain stable during participation in the study
- •Patients must be willing to abstain from taking medications (other than study drug) to help them sleep during participation in the study
- •Patients must be willing to consistently spend at least 7 hours each night either sleeping or trying to sleep during participation in the study
- •Patients must be able to speak and read English and be capable of using a computer with a web browser (computers with internet connections will be provided to patients who need them)
排除标准
- •Unusual or unstable sleep/wake schedule, such as with rotating shift work
- •Severe or unstable psychiatric or medical illness
- •Suicidal ideation
- •Substance abuse
- •Known obstructive sleep apnea, restless leg syndrome, or periodic limb movement disorder
- •History of seizures
- •Body Mass Index > 33
- •Clinically significant abnormality in clinical chemistry, hematology, urinalysis, and/or electrocardiogram
- •Anticipated inability to regularly use a medication which might reduce motor or cognitive functioning during sleeping hours, such as a person who might often need to be "on call", drive a car, or be responsible for the care of another person during sleeping hours
- •Contraindication to zolpidem
- •History of breast cancer
- •An estimated glomerular filtration rate (GFR; an index of renal function) that is <30 mL/min at study entry
研究组 & 干预措施
Period A
2-week double-blind placebo lead-in period. Period A is the first of four 2-week treatment periods.
干预措施: Placebo (Drug)
Period B
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period B is the second of four 2-week treatment periods.
干预措施: LY2624803 (Drug)
Period B
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period B is the second of four 2-week treatment periods.
干预措施: Placebo (Drug)
Period B
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period B is the second of four 2-week treatment periods.
干预措施: zolpidem (Drug)
Period C
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period C is the third of four 2-week treatment periods.
干预措施: LY2624803 (Drug)
Period C
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period C is the third of four 2-week treatment periods.
干预措施: Placebo (Drug)
Period C
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period C is the third of four 2-week treatment periods.
干预措施: zolpidem (Drug)
Period D
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period D is the fourth of four 2-week treatment periods.
干预措施: LY2624803 (Drug)
Period D
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period D is the fourth of four 2-week treatment periods.
干预措施: Placebo (Drug)
Period D
Patients will receive LY2624803, zolpidem or placebo in a sequence of four 2-week treatment periods. Period D is the fourth of four 2-week treatment periods.
干预措施: zolpidem (Drug)
结局指标
主要结局
Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint
时间窗: Baseline, 2 weeks
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
次要结局
- Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint(Baseline, 2 weeks)
- Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint(Baseline, 2 weeks)
- Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint(Baseline, 2 weeks)
- Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint(Baseline, 2 weeks)
- Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint(Baseline, 2 weeks)
- Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint(Baseline, 2 weeks)
- Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint(Baseline, 2 weeks)
- Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint(Baseline, 2 weeks)
- Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint(Baseline, 2 weeks)
- Treatment Satisfaction as Measured by the Participant Drug Preference Question(Baseline (Period A) and 2 weeks (Period B))
- Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint(2 weeks)
- Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint(2 weeks)
- Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type(Baseline, 2 weeks)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type(Baseline through 8 weeks)
- Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group(Baseline, 2 weeks)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group(Baseline through 8 weeks)
- Number of Participants With Treatment Emergent Adverse Events (TEAE)(Baseline through 8 weeks)
- Number of Participants With Serious Adverse Events (SAEs)(Baseline through 8 weeks)
- Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint(Baseline, 2 weeks of treatment over 8 weeks)
- Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint(Baseline, 2 weeks of treatment over 8 weeks)
- Change From Baseline in Weight at Each 2-week Treatment Endpoint(Baseline, 2 weeks of treatment over 8 weeks)
- Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint(2 weeks of treatment over 8 weeks)
- Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint(Baseline, 2 weeks of treatment over 8 weeks)
- Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint(Baseline, 2 weeks of treatment over 8 weeks)