NCT01021852

Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)

A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period Adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK-6096 in Patients With Primary Insomnia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This was a cross-over, polysomnography (PSG) study to test the safety, tolerability and effectiveness of different doses of MK-6096 in the treatment of participants with primary insomnia. The primary efficacy hypothesis was that at least one dose of MK-6096 is superior to placebo in improving sleep efficiency (SE) as measured by PSG on Night 1 and at the end of 4 weeks of treatment (Week 4).

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DRUG	MK-6096	MK-6096 2.5 mg or 5 mg tablets equaling 2.5 mg dose, 5 mg dose, 10 mg dose, or 20 mg dose (depending upon allocation) were taken daily before bedtime for 4 weeks.
DRUG	Dose-matched Placebo to MK-6096	Dose-matched placebo tablets to MK-6096 were taken daily before bedtime during 2-week single-blind run-in, for 4 weeks as a treatment period, and during 2-week washout between treatment periods.

Timeline

• Start date: 2009-11-30
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2009-11-30
• Last updated: 2018-11-06
• Results posted: 2016-06-15