Trial Outcomes & Findings for Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011) (NCT NCT01021852)
NCT ID: NCT01021852
Last Updated: 2018-11-06
Results Overview
SE was measured using a polysomnogram (PSG), which consisted of an electroencephalogram (EEG) for registration of brain activity during sleep, an electro-oculogram (EOG) for registration of the eye movements during sleep, and an electromyogram (EMG) for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to Rechtschaffen and Kales (R\&K) criteria and PSG data were read by a Central Reader. SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each PSG night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100. Least squares (LS) mean SE was reported for each treatment arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
326 participants
Primary outcome timeframe
Night 1 and end of Week 4
Results posted on
2018-11-06
Participant Flow
326 participants were randomized in this study into one of 8 treatment sequences. Participants received double-blind study drug in Treatment Period (TP)1, followed by a washout period (3 day single-blind placebo plus 11 day drug holiday), and then double-blind study drug in TP2.
Participant milestones
| Measure |
MK-6096 2.5 mg/Placebo
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
|
Placebo/MK-6096 2.5 mg
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
|
MK-6096 5 mg/Placebo
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
|
Placebo/MK-6096 5 mg
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
|
MK-6096 10 mg/Placebo
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
|
Placebo/MK-6096 10 mg
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
|
MK-6096 20 mg/Placebo
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
|
Placebo/MK-6096 20 mg
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
40
|
40
|
41
|
40
|
42
|
41
|
41
|
41
|
|
Treatment Period 1
Treated
|
40
|
40
|
41
|
38
|
42
|
41
|
41
|
41
|
|
Treatment Period 1
COMPLETED
|
37
|
39
|
39
|
38
|
39
|
39
|
41
|
40
|
|
Treatment Period 1
NOT COMPLETED
|
3
|
1
|
2
|
2
|
3
|
2
|
0
|
1
|
|
Washout Period-Placebo
STARTED
|
37
|
39
|
39
|
38
|
40
|
39
|
41
|
40
|
|
Washout Period-Placebo
COMPLETED
|
37
|
39
|
39
|
37
|
39
|
38
|
40
|
40
|
|
Washout Period-Placebo
NOT COMPLETED
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
0
|
|
Washout Period-No Drug
STARTED
|
38
|
39
|
39
|
37
|
39
|
39
|
40
|
40
|
|
Washout Period-No Drug
COMPLETED
|
37
|
39
|
39
|
37
|
39
|
38
|
40
|
40
|
|
Washout Period-No Drug
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 2
STARTED
|
37
|
39
|
39
|
37
|
39
|
38
|
40
|
40
|
|
Treatment Period 2
COMPLETED
|
37
|
38
|
38
|
37
|
37
|
37
|
37
|
38
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
1
|
1
|
0
|
2
|
1
|
3
|
2
|
Reasons for withdrawal
| Measure |
MK-6096 2.5 mg/Placebo
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
|
Placebo/MK-6096 2.5 mg
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
|
MK-6096 5 mg/Placebo
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
|
Placebo/MK-6096 5 mg
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
|
MK-6096 10 mg/Placebo
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
|
Placebo/MK-6096 10 mg
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
|
MK-6096 20 mg/Placebo
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
|
Placebo/MK-6096 20 mg
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
|
|---|---|---|---|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
3
|
1
|
1
|
0
|
2
|
2
|
0
|
0
|
|
Treatment Period 1
Pregnancy
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Treatment Period 1
Not Treated
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Washout Period-Placebo
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Washout Period-Placebo
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout Period-Placebo
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Washout Period-No Drug
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 2
Adverse Event
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Treatment Period 2
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 2
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)
Baseline characteristics by cohort
| Measure |
MK-6096 2.5 mg/Placebo
n=40 Participants
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
|
Placebo/MK-6096 2.5 mg
n=40 Participants
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
|
MK-6096 5 mg/Placebo
n=41 Participants
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
|
Placebo/MK-6096 5 mg
n=40 Participants
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
|
MK-6096 10 mg/Placebo
n=42 Participants
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
|
Placebo/MK-6096 10 mg
n=41 Participants
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
|
MK-6096 20 mg/Placebo
n=41 Participants
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
|
Placebo/MK-6096 20 mg
n=41 Participants
Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
|
Total
n=326 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
45.4 years
STANDARD_DEVIATION 9.9 • n=21 Participants
|
45.2 years
STANDARD_DEVIATION 11.0 • n=10 Participants
|
49.8 years
STANDARD_DEVIATION 9.8 • n=115 Participants
|
47.0 years
STANDARD_DEVIATION 12.3 • n=6 Participants
|
46.8 years
STANDARD_DEVIATION 11.0 • n=6 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
25 Participants
n=6 Participants
|
203 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
16 Participants
n=6 Participants
|
123 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Night 1 and end of Week 4Population: Full Analysis Set (FAS) population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization SE efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.
SE was measured using a polysomnogram (PSG), which consisted of an electroencephalogram (EEG) for registration of brain activity during sleep, an electro-oculogram (EOG) for registration of the eye movements during sleep, and an electromyogram (EMG) for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to Rechtschaffen and Kales (R\&K) criteria and PSG data were read by a Central Reader. SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each PSG night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100. Least squares (LS) mean SE was reported for each treatment arm.
Outcome measures
| Measure |
Placebo
n=313 Participants
Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
|
MK-6096 2.5 mg
n=79 Participants
Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 5 mg
n=78 Participants
Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 10 mg
n=80 Participants
Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 20 mg
n=80 Participants
Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
|---|---|---|---|---|---|
|
Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment
Night 1 (n=313, 79, 78, 80, 80)
|
74.8 percentage of time in bed spent sleeping
Standard Error 0.71
|
83.3 percentage of time in bed spent sleeping
Standard Error 1.54
|
84.8 percentage of time in bed spent sleeping
Standard Error 1.55
|
85.6 percentage of time in bed spent sleeping
Standard Error 1.53
|
88.2 percentage of time in bed spent sleeping
Standard Error 1.53
|
|
Sleep Efficiency (SE) on Night 1 and After 4 Weeks of Treatment
Week 4 (n=300, 76, 76, 76, 75)
|
77.0 percentage of time in bed spent sleeping
Standard Error 0.71
|
81.6 percentage of time in bed spent sleeping
Standard Error 1.42
|
81.1 percentage of time in bed spent sleeping
Standard Error 1.42
|
86.7 percentage of time in bed spent sleeping
Standard Error 1.43
|
85.7 percentage of time in bed spent sleeping
Standard Error 1.43
|
PRIMARY outcome
Timeframe: Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)Population: All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. The percentage of participants with AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.
Outcome measures
| Measure |
Placebo
n=315 Participants
Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
|
MK-6096 2.5 mg
n=79 Participants
Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 5 mg
n=78 Participants
Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 10 mg
n=80 Participants
Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 20 mg
n=81 Participants
Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Adverse Event (AE) During Treatment Periods 1 and 2
|
26.0 percentage of participants
|
26.6 percentage of participants
|
25.6 percentage of participants
|
32.5 percentage of participants
|
34.6 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 29 in Treatment Periods 1 and 2 (58 days total)Population: APaT population; all randomized participants who received at least one dose of study treatment. Participants were included corresponding to the study treatment they actually received for a given period.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE. The percentage of participants that discontinued study medication due to AEs are presented for the first day of randomized treatment dosing (Day 1) through the last day of randomized treatment dosing (Day 29) in Treatment Periods 1 and 2.
Outcome measures
| Measure |
Placebo
n=315 Participants
Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
|
MK-6096 2.5 mg
n=79 Participants
Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 5 mg
n=78 Participants
Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 10 mg
n=80 Participants
Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 20 mg
n=81 Participants
Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants That Discontinued Study Medication Due to an AE During Treatment Periods 1 and 2
|
2.2 percentage of participants
|
5.1 percentage of participants
|
1.3 percentage of participants
|
2.5 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Night 1 and end of Week 4Population: FAS population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization WASO efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.
WASO was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R\&K criteria and PSG data were read by a Central Reader. WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on. LS mean WASO was reported for each treatment arm.
Outcome measures
| Measure |
Placebo
n=313 Participants
Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
|
MK-6096 2.5 mg
n=79 Participants
Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 5 mg
n=78 Participants
Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 10 mg
n=80 Participants
Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 20 mg
n=80 Participants
Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
|---|---|---|---|---|---|
|
Wake After Persistent Sleep Onset (WASO) on Night 1 and After 4 Weeks of Treatment
Night 1 (n=313, 79, 78, 80, 80)
|
83.1 minutes
Standard Error 2.81
|
52.3 minutes
Standard Error 6.11
|
50.6 minutes
Standard Error 6.14
|
52.2 minutes
Standard Error 6.06
|
37.3 minutes
Standard Error 6.07
|
|
Wake After Persistent Sleep Onset (WASO) on Night 1 and After 4 Weeks of Treatment
Week 4 (n=300, 76, 76, 76, 75)
|
76.1 minutes
Standard Error 2.77
|
60.6 minutes
Standard Error 5.62
|
62.9 minutes
Standard Error 5.62
|
50.5 minutes
Standard Error 5.63
|
46.1 minutes
Standard Error 5.65
|
SECONDARY outcome
Timeframe: Night 1 and end of Week 4Population: FAS population; subset of all randomized participants who received at least one dose of study medication and had any post-randomization LPS efficacy assessment data. The FAS population may have varied across endpoints due to the degree of missing data for each endpoint.
LPS was measured using a PSG, which consisted of an EEG for registration of brain activity during sleep, an EOG for registration of the eye movements during sleep, and an EMG for recording chin muscle activity during sleep. Sleep stage scoring was performed visually in 30-second epochs according to R\&K criteria and PSG data were read by a Central Reader. LPS was defined as the duration of time measured in minutes from lights off to persistent sleep onset. An epoch of non-wake was defined as a 30-second interval classified as either Stage 1, 2, 3, 4 or REM according to conventional R\&K scoring. LS mean LPS was reported for each treatment arm.
Outcome measures
| Measure |
Placebo
n=313 Participants
Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
|
MK-6096 2.5 mg
n=79 Participants
Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 5 mg
n=78 Participants
Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 10 mg
n=80 Participants
Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 20 mg
n=80 Participants
Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
|---|---|---|---|---|---|
|
Latency to the Onset of Persistent Sleep (LPS) on Night 1 and After 4 Weeks of Treatment
Night 1 (n=313, 79, 78, 80, 80)
|
43.4 minutes
Standard Error 2.06
|
33.2 minutes
Standard Error 4.35
|
27.7 minutes
Standard Error 4.36
|
19.9 minutes
Standard Error 4.32
|
23.0 minutes
Standard Error 4.31
|
|
Latency to the Onset of Persistent Sleep (LPS) on Night 1 and After 4 Weeks of Treatment
Week 4 (n=300, 76, 76, 76, 75)
|
39.4 minutes
Standard Error 2.19
|
30.5 minutes
Standard Error 4.55
|
30.7 minutes
Standard Error 4.55
|
19.9 minutes
Standard Error 4.57
|
28.1 minutes
Standard Error 4.58
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
MK-6096 2.5 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-6096 5 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
MK-6096 10 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
MK-6096 20 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Washout
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Post-Study/Follow-up
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=315 participants at risk
Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
|
MK-6096 2.5 mg
n=79 participants at risk
Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 5 mg
n=78 participants at risk
Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 10 mg
n=80 participants at risk
Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 20 mg
n=81 participants at risk
Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
Washout
n=315 participants at risk
Participants administered single-blind placebo study medication for the first 3 nights of the washout period that occurred between Treatment Period 1 and Treatment Period 2, immediately prior to bedtime. The remaining 11 days of the washout period constituted a drug holiday during which time no study medication was administered.
|
Post-Study/Follow-up
n=324 participants at risk
Participants that completed the study or prematurely discontinued during either treatment period received a 14-day (from last dose) follow-up phone call to assess for AEs. The Post-Study/Follow-up period was the period that occurred between study completion/ treatment discontinuation and the 14-day follow-up phone call (14 days after the last dose of double-blind study medication).
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/315 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/79 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
1.3%
1/78 • Number of events 1 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/80 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/81 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/315 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/324 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/315 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/79 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/78 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
1.2%
1/80 • Number of events 1 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/81 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/315 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.31%
1/324 • Number of events 1 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/315 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
1.3%
1/79 • Number of events 1 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/78 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/80 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/81 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/315 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/324 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
|
Nervous system disorders
Syncope
|
0.00%
0/315 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/79 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
1.3%
1/78 • Number of events 1 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/80 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/81 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/315 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/324 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/315 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/79 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/78 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/80 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/81 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.32%
1/315 • Number of events 1 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/324 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
Other adverse events
| Measure |
Placebo
n=315 participants at risk
Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
|
MK-6096 2.5 mg
n=79 participants at risk
Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 5 mg
n=78 participants at risk
Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 10 mg
n=80 participants at risk
Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
MK-6096 20 mg
n=81 participants at risk
Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
|
Washout
n=315 participants at risk
Participants administered single-blind placebo study medication for the first 3 nights of the washout period that occurred between Treatment Period 1 and Treatment Period 2, immediately prior to bedtime. The remaining 11 days of the washout period constituted a drug holiday during which time no study medication was administered.
|
Post-Study/Follow-up
n=324 participants at risk
Participants that completed the study or prematurely discontinued during either treatment period received a 14-day (from last dose) follow-up phone call to assess for AEs. The Post-Study/Follow-up period was the period that occurred between study completion/ treatment discontinuation and the 14-day follow-up phone call (14 days after the last dose of double-blind study medication).
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
3.8%
12/315 • Number of events 14 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
3.8%
3/79 • Number of events 3 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
3.8%
3/78 • Number of events 4 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
6.2%
5/80 • Number of events 5 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
3.7%
3/81 • Number of events 3 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
1.3%
4/315 • Number of events 4 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/324 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
|
Nervous system disorders
Somnolence
|
2.9%
9/315 • Number of events 9 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
1.3%
1/79 • Number of events 1 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
2.6%
2/78 • Number of events 2 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
6.2%
5/80 • Number of events 6 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
13.6%
11/81 • Number of events 13 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.32%
1/315 • Number of events 1 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
0.00%
0/324 • From time of first dose through follow-up (up to 86 days)
APaT population; all randomized participants who received ≥1 dose of study treatment. Participants in a treatment arm were counted once for each therapy received during a Treatment Period (TP), and the same participant may have been counted twice: once for the therapy assigned for TP 1 and once for the therapy assigned for TP2.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60