Trial Outcomes & Findings for Study to Compare the Awakening Threshold Effects of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs (NCT NCT03312517)
NCT ID: NCT03312517
Last Updated: 2019-11-01
Results Overview
Subjects will be awakened during the night to auditory awakening tones.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
2.5 hours post-dose of each Study Drug administration
Results posted on
2019-11-01
Participant Flow
Presence of insomnia determined by clinical interview performed by a physician board certified in sleep medicine
Participant milestones
| Measure |
Placebo Then Suvorexant 10mg, Then Suvorexant 20mg
Subjects first received Placebo, then Suvorexant 10mg, then Suvorexant 20mg. Treatment was administered 30 min. before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
|
Placebo, Then Suvorexant 20mg, Then Suvorexant 10mg
Subjects first received Placebo, then Suvorexant 20mg, then Suvorexant 10mg. Treatment was administered 30 min. before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
|
Suvorexant 10, Then Placebo, Then Suvorexant 20
Subjects first received Suvorexant 10mg, then placebo, then Suvorexant 20mg. Treatment was administered 30 min. before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
|
Suvorexant 10mg, Then Suvorexant 20mg, Then Placebo
Subjects first received Suvorexant 10mg, then Suvorexant 20mg, then placebo. Treatment was administered 30 min. before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
|
Suvorexant 20mg, Placebo, Suvorexant 10mg
Subjects first received Suvorexant 20mg, placebo, then Suvorexant 10mg. Treatment was administered 30 min. before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
|
Suvorexant 20, Suvorexant 10mg, Placebo
Subjects first received Suvorexant 20, then Suvorexant 10mg, then Placebo. Treatment was administered 30 min. before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Compare the Awakening Threshold Effects of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs
Baseline characteristics by cohort
| Measure |
Analyzed Sample
n=12 Participants
Crossover study, all subjects will receive belsomra 10mg, belsomra 20mg and placebo before bedtime in 3 separate overnights. In the middle of the night, subjects will be awakened to auditory awakening tones.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Number of participants in analysis
|
12 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2.5 hours post-dose of each Study Drug administrationPopulation: We compared the odds of individuals sleeping through a 85-db stimulus in each condition. A generalized linear mixed model was used to estimate binary outcomes
Subjects will be awakened during the night to auditory awakening tones.
Outcome measures
| Measure |
Suvorexant 10mg
n=12 Participants
Subjects will receive belsomra 10mg before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
Suvorexant 10 mg: Subject will receive suvorexant 10mg
|
Suvorexant 20mg
n=12 Participants
Subjects will receive belsomra 20mg before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
Suvorexant 20 mg: Subject will receive suvorexant 20mg
|
Placebo Oral Capsule
n=12 Participants
Subjects will receive placebo before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
Placebo oral capsule: Subject will receive placebo.
|
|---|---|---|---|
|
Auditory Awakening Threshold
|
74.17 decibels (db)
Standard Deviation 23.44
|
83.75 decibels (db)
Standard Deviation 20.24
|
79.17 decibels (db)
Standard Deviation 22.34
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Belsomra 20mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Belsomra 10mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=12 participants at risk
All 12 subjects received placebo, 30 min before bedtime in one of the treatment nights. Order of treatment was assigned randomly. In the middle of the night, subjects were awakened to auditory awakening tones.
|
Belsomra 20mg
n=12 participants at risk
All 12 subjects received belsomra 20mg, 30 min before bedtime in one of the treatment nights. Order of treatment was assigned randomly. In the middle of the night, subjects were awakened to auditory awakening tones.
|
Belsomra 10mg
n=12 participants at risk
All 12 subjects received belsomra 10mg, 30 min before bedtime in one of the treatment nights. Order of treatment was assigned randomly. In the middle of the night, subjects were awakened to auditory awakening tones.
|
|---|---|---|---|
|
Nervous system disorders
Dry Mouth
|
0.00%
0/12 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
8.3%
1/12 • Number of events 1 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
0.00%
0/12 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
8.3%
1/12 • Number of events 1 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
0.00%
0/12 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
|
Psychiatric disorders
Upset
|
0.00%
0/12 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
8.3%
1/12 • Number of events 1 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
0.00%
0/12 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
8.3%
1/12 • Number of events 1 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
0.00%
0/12 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
|
Nervous system disorders
Tingling sensation in arm
|
0.00%
0/12 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
8.3%
1/12 • Number of events 1 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
0.00%
0/12 • 2 weeks
Adverse Event were collected before and after every overnight. In addition, a Safety Follow-up 2 weeks after either study completion or study withdrawal was performed.
|
Additional Information
Christopher Drake, PhD
Henry Ford Sleep Research Center
Phone: 248-344-6672
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place