Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)

Primary Insomnia Clinical Trial

Official title:

A Phase IIb, Multicenter, Randomized, Double-Blind Placebo-Controlled, 2-period Adaptive Crossover Polysomnography Study to Evaluate Safety and Efficacy of MK-4305 in Patients With Primary Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792298
• Other study ID #: 4305-006
• Secondary ID: 2008_583
• Status: Completed
• Phase: Phase 2
• Start date: November 5, 2008
• Est. completion date: December 26, 2009

Study information

• Verified date: October 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: December 26, 2009
• Est. primary completion date: December 26, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Suvorexant
oral tablet taken before bedtime
• Dose-matched Placebo to Suvorexant
Dose-matched placebo to suvorexant taken before bedtime (oral tablet)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Herring WJ, Snyder E, Budd K, Hutzelmann J, Snavely D, Liu K, Lines C, Roth T, Michelson D. Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. Neurology. 2012 Dec 4;79(23):2265-74. doi: 10.1212/WNL.0b013e31827 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LS Mean Sleep Efficiency (SE) During Periods 1 and 2	SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography [PSG] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100	Night 1 and end of Week 4
Secondary	LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2	WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on.	Night 1 and end of Week 4
Secondary	LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2	LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset.	Night 1 and end of Week 4