Phase 2
N=254
Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)
Primary Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT00792298 ↗Enrolled (actual)
254
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: LS Mean Sleep Efficiency (SE) During Periods 1 and 2 — 75.8; 81.0; 83.4; 86.6 percent of time in bed — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Suvorexant (Drug); Dose-matched Placebo to Suvorexant (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LS Mean Sleep Efficiency (SE) During Periods 1 and 2 |
75.8; 81.0; 83.4; 86.6; 88.7; 76.6 | <0.001 sig |
| SECONDARY LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2 |
72.4; 51.3; 47.7; 38.5; 35.6; 76.7 | <0.001 sig |
| SECONDARY LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2 |
49.8; 46.4; 40.4; 26.7; 24.4; 41.7 | <0.001 sig |
Summary
A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.
Eligibility Criteria
Inclusion Criteria
- Has a diagnosis of Primary Insomnia based on sleep history and the investigator's judgment
- Must be willing to stay overnight at a sleep laboratory
- Must be willing to stay in bed for at least 8 hours each night while at the sleep laboratory
- Regular bedtime is between 9 PM and 12 AM (midnight)
Exclusion Criteria
- Breast feeding, pregnant or planning to become pregnant during the study
- Within the past 6 months before starting the study you have a history of significant cardiovascular disorder such as unstable angina, congestive heart - failure or acute coronary syndrome
- Currently participating or have participated in a study with an investigational compound or device within the last 30 days
- Has traveled across 3 or more time zones in the last 2 weeks or plans on traveling across 3 or more time zones at any time during the study
- Has done shift work within the past 2 weeks
- Has donated blood products within the last 8 weeks
- Has difficulty sleeping due to a medical condition
Data sourced from ClinicalTrials.gov (NCT00792298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.