Trial Outcomes & Findings for Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061) (NCT NCT02750306)
NCT ID: NCT02750306
Last Updated: 2019-10-16
Results Overview
TST was measured at Baseline and at Week 4 in a sleep laboratory by polysomnography, during an 8-hour recording period beginning at participants' habitual bedtime.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
285 participants
Primary outcome timeframe
Baseline and Week 4
Results posted on
2019-10-16
Participant Flow
Participant milestones
| Measure |
Suvorexant
Participants received 1 suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' suvorexant dose could be increased to 20 mg if their Clinical Global Impression of Insomnia Severity (CGI-S) was ≥3 and investigators felt they could tolerate the increased dose.
|
Placebo
Participants received 1 placebo-matching suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' placebo-matching dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
143
|
|
Overall Study
COMPLETED
|
136
|
141
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Suvorexant
Participants received 1 suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' suvorexant dose could be increased to 20 mg if their Clinical Global Impression of Insomnia Severity (CGI-S) was ≥3 and investigators felt they could tolerate the increased dose.
|
Placebo
Participants received 1 placebo-matching suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' placebo-matching dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
All Participants Treated/Data-as-Observed (One participant who failed the screening was inadvertently randomized and treated with suvorexant; had no polysomnography-derived total sleep time data.)
Baseline characteristics by cohort
| Measure |
Suvorexant
n=142 Participants
Participants received 1 suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' suvorexant dose could be increased to 20 mg if their Clinical Global Impression of Insomnia Severity (CGI-S) was ≥3 and investigators felt they could tolerate the increased dose.
|
Placebo
n=143 Participants
Participants received 1 placebo-matching suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' placebo-matching dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
|
Total
n=285 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.6 Years
STANDARD_DEVIATION 8.7 • n=142 Participants
|
69.1 Years
STANDARD_DEVIATION 8.5 • n=143 Participants
|
69.3 Years
STANDARD_DEVIATION 8.6 • n=285 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=142 Participants
|
95 Participants
n=143 Participants
|
186 Participants
n=285 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=142 Participants
|
48 Participants
n=143 Participants
|
99 Participants
n=285 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
89 Participants
n=142 Participants
|
93 Participants
n=143 Participants
|
182 Participants
n=285 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=142 Participants
|
50 Participants
n=143 Participants
|
102 Participants
n=285 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=142 Participants
|
0 Participants
n=143 Participants
|
1 Participants
n=285 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=142 Participants
|
12 Participants
n=143 Participants
|
17 Participants
n=285 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=142 Participants
|
3 Participants
n=143 Participants
|
5 Participants
n=285 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=142 Participants
|
1 Participants
n=143 Participants
|
1 Participants
n=285 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=142 Participants
|
22 Participants
n=143 Participants
|
46 Participants
n=285 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=142 Participants
|
80 Participants
n=143 Participants
|
166 Participants
n=285 Participants
|
|
Race (NIH/OMB)
More than one race
|
25 Participants
n=142 Participants
|
25 Participants
n=143 Participants
|
50 Participants
n=285 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=142 Participants
|
0 Participants
n=143 Participants
|
0 Participants
n=285 Participants
|
|
Polysomnography-derived Total Sleep Time
|
279.1 Minutes
STANDARD_DEVIATION 76.6 • n=141 Participants • All Participants Treated/Data-as-Observed (One participant who failed the screening was inadvertently randomized and treated with suvorexant; had no polysomnography-derived total sleep time data.)
|
271.2 Minutes
STANDARD_DEVIATION 86.7 • n=143 Participants • All Participants Treated/Data-as-Observed (One participant who failed the screening was inadvertently randomized and treated with suvorexant; had no polysomnography-derived total sleep time data.)
|
275.1 Minutes
STANDARD_DEVIATION 81.8 • n=284 Participants • All Participants Treated/Data-as-Observed (One participant who failed the screening was inadvertently randomized and treated with suvorexant; had no polysomnography-derived total sleep time data.)
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: All randomized participants who received at least 1 dose of study medication, had a baseline value for change from baseline analyses, and at least 1 post-randomization observation for the analysis endpoint subsequent to at least 1 dose of study medication
TST was measured at Baseline and at Week 4 in a sleep laboratory by polysomnography, during an 8-hour recording period beginning at participants' habitual bedtime.
Outcome measures
| Measure |
Suvorexant
n=135 Participants
Participants received 1 suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' suvorexant dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
|
Placebo
n=139 Participants
Participants received 1 placebo-matching suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' placebo-matching dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
|
|---|---|---|
|
Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4
|
73.4 Minutes
Interval 61.3 to 85.5
|
45.2 Minutes
Interval 33.3 to 57.2
|
PRIMARY outcome
Timeframe: Up to 6 weeksPopulation: All randomized participants who received at least 1 dose of study medication
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Outcome measures
| Measure |
Suvorexant
n=142 Participants
Participants received 1 suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' suvorexant dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
|
Placebo
n=143 Participants
Participants received 1 placebo-matching suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' placebo-matching dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
|
|---|---|---|
|
Percentage of Participants Who Experienced One or More Adverse Events
|
22.5 Percentage of participants
|
16.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: All randomized participants who received at least 1 dose of study medication
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Outcome measures
| Measure |
Suvorexant
n=142 Participants
Participants received 1 suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' suvorexant dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
|
Placebo
n=143 Participants
Participants received 1 placebo-matching suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' placebo-matching dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
|
|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
|
0.7 Percentage of participants
|
0.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: All randomized participants who received at least 1 dose of study medication, had a baseline value for change from baseline analyses, and at least 1 post-randomization observation for the analysis endpoint subsequent to at least 1 dose of study medication
WASO was measured at Baseline and at Week 4 in a sleep laboratory by polysomnography during an 8-hour recording period beginning at participants' habitual bedtime.
Outcome measures
| Measure |
Suvorexant
n=134 Participants
Participants received 1 suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' suvorexant dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
|
Placebo
n=137 Participants
Participants received 1 placebo-matching suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' placebo-matching dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
|
|---|---|---|
|
Change From Baseline in Polysomnography-derived Wakefulness After Persistent Sleep Onset (WASO) at Week 4
|
-45.0 Minutes
Interval -53.8 to -36.3
|
-29.4 Minutes
Interval -38.1 to -20.7
|
Adverse Events
Suvorexant
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Suvorexant
n=142 participants at risk
Participants received 1 suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' suvorexant dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
|
Placebo
n=143 participants at risk
Participants received 1 placebo-matching suvorexant tablet every night for up to 4 weeks. After 2 weeks of double-blind treatment at 10 mg, participants' placebo-matching dose could be increased to 20 mg if their CGI-S was ≥3 and investigators felt they could tolerate the increased dose.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.70%
1/142 • Number of events 1 • Up to 6 weeks
All randomized participants who received at least 1 dose of study medication
|
0.00%
0/143 • Up to 6 weeks
All randomized participants who received at least 1 dose of study medication
|
Other adverse events
Adverse event data not reported
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 The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER