Trials / Completed
CompletedNCT02750306
Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061)
A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Subjects With Alzheimer's Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 285 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 50 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to examine the safety and efficacy of suvorexant (MK-4305) to improve sleep in individuals with Alzheimer's disease (AD). The primary hypothesis for the study is that suvorexant is superior to placebo in improving insomnia as measured by change from baseline in polysomnography (PSG)-derived total sleep time (TST) at Week 4.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Suvorexant | 10 mg tablet (may be increased to 20 mg tablet) |
| DRUG | Placebo | Placebo to suvorexant |
Timeline
- Start date
- 2016-05-23
- Primary completion
- 2018-09-30
- Completion
- 2018-09-30
- First posted
- 2016-04-25
- Last updated
- 2019-10-16
- Results posted
- 2019-10-16
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02750306. Inclusion in this directory is not an endorsement.