Trial · NCT02750306
Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061)
NCT02750306, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2019-10-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061). Trials, record NCT02750306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02750306
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061)
- NCT number
- NCT02750306
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 285 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Sleep Initiation and Maintenance Disorders, Alzheimer Disease
- Interventions
- Suvorexant, Placebo
- First posted
- 2016-04-25
- Last updated
- 2019-10-16
- Other registries' IDs
- eudract:2015-003154-40
- Results first posted
- 2019-10-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4 | Baseline and Week 4 | 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. |
| Primary | Percentage of Participants Who Experienced One or More Adverse Events | Up to 6 weeks | 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. |
| Primary | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to 4 weeks | 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. |
| Secondary | Change From Baseline in Polysomnography-derived Wakefulness After Persistent Sleep Onset (WASO) at Week 4 | Baseline and Week 4 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4 | Baseline and Week 4 | 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 | Minutes | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Who Experienced One or More Adverse Events | Up to 6 weeks | All randomized participants who received at least 1 dose of study medication | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Up to 4 weeks | All randomized participants who received at least 1 dose of study medication | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Polysomnography-derived Wakefulness After Persistent Sleep Onset (WASO) at Week 4 | Baseline and Week 4 | 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 | Minutes | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4 | Suvorexant | 73.4 | 95% Confidence Interval 61.3 to 85.5 | Minutes | |
| Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4 | Placebo | 45.2 | 95% Confidence Interval 33.3 to 57.2 | Minutes | |
| Percentage of Participants Who Experienced One or More Adverse Events | Suvorexant | 22.5 | Percentage of participants | ||
| Percentage of Participants Who Experienced One or More Adverse Events | Placebo | 16.1 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Suvorexant | 0.7 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event | Placebo | 0.7 | Percentage of participants | ||
| Change From Baseline in Polysomnography-derived Wakefulness After Persistent Sleep Onset (WASO) at Week 4 | Suvorexant | -45.0 | 95% Confidence Interval -53.8 to -36.3 | Minutes | |
| Change From Baseline in Polysomnography-derived Wakefulness After Persistent Sleep Onset (WASO) at Week 4 | Placebo | -29.4 | 95% Confidence Interval -38.1 to -20.7 | Minutes |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Suvorexant | 142 | |
| Overall Study | STARTED | Placebo | 143 | |
| Overall Study | COMPLETED | Suvorexant | 136 | |
| Overall Study | COMPLETED | Placebo | 141 | |
| Overall Study | NOT COMPLETED | Suvorexant | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Ankle fracture | Injury, poisoning and procedural complications | Suvorexant | 1 | 142 | 1 |
| serious | Ankle fracture | Injury, poisoning and procedural complications | Placebo | 0 | 143 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Suvorexant | 0 | 142 |
| Total, all-cause mortality | Placebo | 0 | 143 |
| Total, other adverse events | Suvorexant | 0 | 142 |
| Total, other adverse events | Placebo | 0 | 143 |
| Total, serious adverse events | Suvorexant | 1 | 142 |
| Total, serious adverse events | Placebo | 0 | 143 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Suvorexant vs Placebo: deaths from any cause | Trial comparisons |
| Suvorexant vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02750306
GET https://conductscience.org/api/trials/v1/NCT02750306/registered