NCT03375203

A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia Disorders

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo will be administered once daily based upon dosing group.
DRUG	JNJ-42847922, 5 mg	JNJ-42847922 will be administered as 5 mg (2\*2.5 mg capsule) oral capsules once daily.
DRUG	JNJ-42847922, 10 mg	JNJ-42847922 will be administered as 10 mg oral capsule once daily.
DRUG	JNJ-42847922, 20 mg	JNJ-42847922 will be administered as 20 mg oral capsule once daily.
DRUG	Zolpidem	Zolpidem will be administered as 5 mg or 10 mg (2\*5mg capsule) oral capsule once daily based upon the local labeling information.

Timeline

• Start date: 2017-11-23
• Primary completion: 2019-04-03
• Completion: 2019-04-03
• First posted: 2017-12-15
• Last updated: 2025-04-29
• Results posted: 2022-05-23

Locations

56 sites across 6 countries: United States, Belgium, France, Germany, Japan, Poland

Regulatory

• FDA-regulated drug study