At a glance
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A Multicenter, Double-Blind, Randomized, Parallel-Group, Active- and Placebo-Controlled Polysomnography Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Subjects With Insomnia Disorder
In Brief
A Phase 2 clinical trial evaluating Placebo, JNJ-42847922, 5 mg, and 3 other interventions for Insomnia Disorders. Completed, enrolled 365 participants across 56 sites in 6 countries.
Detailed Summary
The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant) upon multiple (14 days) dose administration in participants with insomnia disorder.
Study Details
Timeline
Interventions
Matching placebo will be administered once daily based upon dosing group.
JNJ-42847922 will be administered as 5 mg (2\*2.5 mg capsule) oral capsules once daily.
JNJ-42847922 will be administered as 10 mg oral capsule once daily.
JNJ-42847922 will be administered as 20 mg oral capsule once daily.
Zolpidem will be administered as 5 mg or 10 mg (2\*5mg capsule) oral capsule once daily based upon the local labeling information.