Study to Evaluate Efficacy, Safety and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder Without Psychiatric Comorbidity

Phase 2 Completed 28 enrolled Janssen Research & Development, LLC

RandomizedCrossoverDouble-blindTreatment

Summary

The primary purpose of this study is to investigate the effect of JNJ-42847922 (change versus placebo) on sleep efficiency (SE) measured by polysomnography (PSG) after single and multiple dose administration to participants with insomnia disorder without psychiatric comorbidity.

Timeline

Start: 2015-07-27
Primary completion: 2015-12-02
Completion: 2015-12-02

Outcome

Met primary endpoint

paper Sleep efficiency was increased with seltorexant treatment compared with placebo. PMID 29848147 ↗

paper 5.8 (9.2), and 7.9 (9.8) at Day 5/6 ( p < 0.001 at both time points); PMID 29848147 ↗

release “clinical trial (ISM2005) of seltorexant (MIN-202) in patients with insomnia disorder that demonstrated highly statistically significant (p ≤0.001) and clinically meaningful improvement on LPS” minervaneurosciences.com ↗

Publications

De Boer P, Drevets WC, Rofael H, van der Ark P, Kent JM, Kezic I, Parapatics S, Dorffner G, van Gerven J, Benes H, Keicher C, Jahn H, Seiden DJ, Luthringer R. A randomized Phase 2 study to evaluate the orexin-2 receptor antagonist seltorexant in individuals with insomnia without psychiatric comorbidity. J Psychopharmacol. 2018 Jun;32(6):668-677. doi: 10.1177/0269881118773745. Epub 2018 May 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Seltorexant	Small molecule	40 mg	Oral