A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomnia - Study A
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,023
- 主要终点
- Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3
研究概览
简要总结
This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep. Participants who complete the initial 3-month Treatment (TRT) Phase may participate in an optional 3-month Extension (EXT) Phase.
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
- •Must be ≥18 yrs old on the day of signing informed consent
- •Diagnosed with Primary Insomnia
- •Good physical and mental health
- •Participant ≥65 yrs old score at least 25 on the Mini Mental State Examination
- •A female participant who is of reproductive potential has a negative serum pregnancy test and agrees to use contraception
- •Reports difficulty with initiating and maintaining sleep during the 4 weeks prior to Visit 1 (accordingly to specific protocol criteria)
- •Reports spending 6.5 to 9 hours nightly in bed on at least 3 out of 7 nights prior to Visit 1
- •Regular bedtime is between 9 pm-1 am
- •Willing to refrain from napping while in study
- •Able to read, understand and complete questionnaires and all diaries
- •Willing to limit alcohol, caffeine, and nicotine consumption while in the study
- •For a portion of participants: Must be willing to stay overnight in a sleep laboratory and must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory
排除标准
- •Female participant is pregnant and/or breastfeeding at Prestudy visit, or expecting to conceive while in study
- •History or diagnosis of another sleep disorder
- •Difficulty sleeping due to a medical condition
- •History of a neurological disorder
- •History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication
- •Ongoing depression
- •History of substance abuse or dependence
- •History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at Prestudy Visit
- •Taking certain prohibited medications
- •Consumption of the equivalent of >15 cigarettes a day
- •History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- •Participant is considered morbidly obese
- •Previously randomized in another investigational study of suvorexant
研究组 & 干预措施
Suvorexant HD
Drug
干预措施: Suvorexant High Dose (HD) (Drug)
Suvorexant LD
Drug
干预措施: Suvorexant Low Dose (LD) (Drug)
结局指标
主要结局
Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3
时间窗: Baseline and Month 3
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1
时间窗: Baseline and Month 1
WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Number of Participants With an Adverse Event (AE) During Initial 3-Month DB TRT Phase
时间窗: Up to 3 months
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants with an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.
Number of Participants Who Discontinued Study Drug Due to an AE Occurring During Initial 3-Month DB TRT Phase
时间窗: Up to 3 months
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Participants who discontinued study drug treatment due to an AE occurring during the initial 3-month DB TRT Phase are counted once in this summary.
Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1
时间窗: Baseline and Month 1
sTSTm is the average over a defined day range of the participant's report of the total amount of time spent asleep before waking for the day, as recorded in a daily electronic diary (e-diary). Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any polysomnography \[PSG\] nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3
时间窗: Baseline and Month 3
WASO is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1
时间窗: Baseline and Month 1
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 1 range is Days 23-30 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3
时间窗: Baseline and Month 3
sTSOm is the average over a defined day range of the participant's report of the duration of time that it took to fall asleep, as recorded in a daily e-diary. Averages were derived by taking the mean of all available daily measurements (excluding the mornings following any PSG nights) falling within the day range; Month 3 range is Days 76-90 (Day 1 is day of first double-blind dose). A participant must have at least 3 days of data during the defined day range to calculate an average for the day range; otherwise, the mean value was considered missing for that day range. The baseline value is the mean of the last 7 daily measurements obtained during the placebo Run-in period.
Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1
时间窗: Baseline and Month 1
LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3
时间窗: Baseline and Month 3
LPS is measured during overnight sleep laboratory (PSG) assessments at baseline, Night 1, Month 1 and Month 3, and is defined as the duration of time from the beginning of PSG assessment ("Lights-Off") to the first interval of 10 consecutive minutes of sleep. Beginning of PSG assessment ("Lights-Off") is at approximately the participant's habitual bedtime. The participant is awakened, or allowed to get out of bed if already awake, after 8 hours of PSG recording ("Lights-On"). PSG assessments consist of electronic measurement of brain activity and eye and muscle movements. PSG data was scored by a Centralized PSG reading center.
次要结局
- Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSTm at Week 1(Baseline and Week 1)
- Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 1(Baseline and Month 1)
- Suvorexant LD Versus Placebo: Change From Baseline in sTSTm at Month 3(Baseline and Month 3)
- Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 1(Baseline and Month 1)
- Suvorexant LD/HD Versus Placebo: Change From Baseline in WASO at Night 1(Baseline and Night 1)
- Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 1(Baseline and Month 1)
- Suvorexant LD Versus Placebo: Change From Baseline in sTSOm at Month 3(Baseline and Month 3)
- Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 3(Baseline and Month 3)
- Suvorexant LD Versus Placebo: Change From Baseline in WASO at Month 3(Baseline and Month 3)
- Suvorexant LD/HD Versus Placebo: Change From Baseline in sTSOm at Week 1(Baseline and Week 1)
- Suvorexant LD/HD Versus Placebo: Change From Baseline in LPS at Night 1(Baseline and Night 1)
- Suvorexant LD Versus Placebo: Change From Baseline in LPS at Month 1(Baseline and Month 1)