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

NCT02464046 | Completed Phase 2 FDA Drug

• 3 other identifiers: CR10758542847922ISM20022015-001672-22
• Study Type: interventional
• Target: 28
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Insomnia

Keywords

Insomnia; JNJ-42847922; Placebo

Outcome Measures

Primary Outcomes (1)

• Sleep Efficiency by Polysomnography

  The total sleep time divided by the total time in bed (that is, the number of minutes from the beginning of the Polysomnography recording to the end of the recording).

  up to Night 5

Secondary Outcomes (11)

• Total Sleep Time by Polysomnography

  up to Night 5

• Wake Time After Sleep Onset by Polysomnography

  up to Night 5

• Number of Awakenings After Persistent Sleep by Polysomnography

  up to Night 5

• Total Time Spent in Deep Sleep by Polysomnography

  up to Night 5

• Mean Latency to Persistent Sleep by Polysomnography

  up to Night 5

Study Arms (2)

JNJ-42847922 then Placebo

EXPERIMENTAL

Participants receive 2\*20 milligram (mg) tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 of period 1. After a washout period of 5 to 9 days participants will receive matching placebo from Day 1 to Day 5 of period 2.

Drug: JNJ-42847922; Drug: Placebo

Placebo then JNJ-42847922

EXPERIMENTAL

Participants will receive matching placebo from Day 1 to Day 5 of period 1. After a washout period of 5 to 9 days participants will receive 2\*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 of period 2.

Drug: JNJ-42847922; Drug: Placebo

Interventions

JNJ-42847922 DRUG

Participants in arm JNJ-42847922 then Placebo will receive 2\*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 in Period 1 and participants in arm Placebo then JNJ-42847922 will receive 2\*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 in Period 2.

JNJ-42847922 then Placebo; Placebo then JNJ-42847922

Placebo DRUG

Participants in arm JNJ-42847922 then Placebo will receive matching Placebo orally once daily from Day 1 to Day 5 in Period 2 and participants in arm Placebo then JNJ-42847922 will receive matching placebo orally once daily from Day 1 to Day 5 in Period 1.

JNJ-42847922 then Placebo; Placebo then JNJ-42847922

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female participants aged between 18 and 65 years, inclusive
• Body mass index (BMI) between 18 and 30 kilogram per square meters (kg/m\^2) inclusive (BMI = weight/height\^2)
• Insomnia Severity Index (ISI) score more than or equal to (\>=) 15 at screening
• Participants must be healthy / medically stable on the basis of clinical laboratory tests, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline

You may not qualify if:

• Participant has current signs/symptoms of, liver or renal insufficiency; hypothyroidism or hyperthyroidism, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbances. Participants with non-insulin dependent diabetes mellitus who are adequately controlled (not on insulin) may participate in the study
• History of epilepsy or fits or unexplained black-outs
• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission
• Clinically significant abnormal physical and neurological examination, vital signs or 12-lead ECG at screening or baseline
• Smoking \>=10 cigarettes/daily
• Insomnia related to restless leg syndrome, sleep breathing disorder, narcolepsy, obstructive sleep apnea/hypopnea, central sleep apnea, sleep-related hypoventilation, circadian rhythm sleep-wake disorders, substance/medication-induced sleep disorder or parasomnias
• Night-shift worker or significantly shifted diurnal activity pattern

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (5)

Unknown Facility

Hollywood, Florida, United States

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Schwerin, Germany

Location

Unknown Facility

Leiden, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 29848147 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

seltorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Janssen Research & Development, LLC Clinical trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 8, 2015
• Study Start: July 27, 2015
• Primary Completion: December 2, 2015
• Study Completion: December 2, 2015
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

NL (1); US (1); DE (3)