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

NCT03375203 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: CR10842742847922ISM20052017-000980-33
• Study Type: interventional
• Target: 365
• Locations: 6 countries
• Sites: 56

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1

  Change in LPS was measured on Night 1 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. The LPS change from baseline on Night 1 was calculated as (LPS at Night 1 minus Baseline LPS). Negative changes in LPS indicated improvement.

  Baseline and Night 1

Secondary Outcomes (46)

• Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1

  Baseline and over first 6 hours on Night 1

• Change From Baseline in LPS as Measured by PSG on Night 13

  Baseline and Night 13

• Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13

  Baseline and over first 6 hours on Night 13

• Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13

  Baseline, Over 6 hours on Nights 1 and 13

• Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13

  Baseline, Over 8 hours on Nights 1 and 13

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo to JNJ-42847922 as oral capsules at normal study bedtime on Nights 1 through 14.

Drug: Placebo

JNJ-42847922 5 milligram (mg)

EXPERIMENTAL

Participant will receive JNJ-42847922 5 mg dose as oral capsules at normal study bedtime on Nights 1 through 14.

Drug: JNJ-42847922, 5 mg

JNJ-42847922 10 mg plus Placebo

EXPERIMENTAL

Participant will receive JNJ-42847922 10 mg as oral capsule and one placebo capsule at normal study bedtime on Nights 1 through 14.

Drug: Placebo; Drug: JNJ-42847922, 10 mg

JNJ-42847922 20 mg plus Placebo

EXPERIMENTAL

Participant will receive JNJ-42847922 20 mg as oral capsule and one placebo capsule at normal study bedtime on Nights 1 through 14.

Drug: Placebo; Drug: JNJ-42847922, 20 mg

Zolpidem plus Placebo

EXPERIMENTAL

Participants will receive Zolpidem 5 mg plus one placebo capsule or 10 mg dose as oral capsule at normal study bedtime on Nights 1 through 14.

Drug: Placebo; Drug: Zolpidem

Interventions

Placebo DRUG

Matching placebo will be administered once daily based upon dosing group.

JNJ-42847922 10 mg plus Placebo; JNJ-42847922 20 mg plus Placebo; Placebo; Zolpidem plus Placebo

JNJ-42847922, 5 mg DRUG

JNJ-42847922 will be administered as 5 mg (2\*2.5 mg capsule) oral capsules once daily.

Also known as: MIN-202;, Seltorexant

JNJ-42847922 5 milligram (mg)

JNJ-42847922, 10 mg DRUG

JNJ-42847922 will be administered as 10 mg oral capsule once daily.

Also known as: MIN-202;, Seltorexant

JNJ-42847922 10 mg plus Placebo

JNJ-42847922, 20 mg DRUG

JNJ-42847922 will be administered as 20 mg oral capsule once daily.

Also known as: MIN-202;, Seltorexant

JNJ-42847922 20 mg plus Placebo

Zolpidem DRUG

Zolpidem will be administered as 5 mg or 10 mg (2\*5mg capsule) oral capsule once daily based upon the local labeling information.

Zolpidem plus Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be a man or women of non-childbearing potential (WONCBP), 18 to 85 years of age, inclusive, on the day of signing informed consent. A WONCBP is defined as: a).Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. b). Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. c). If reproductive status is questionable, additional evaluation should be considered
• Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder
• Participant must have an Insomnia Severity Index (ISI) total score greater than or equal to (\>=) 15 at screening
• Participant must have an self-reported sleep onset latency (sSOL) \>=45 minutes and a subjective wake after sleep onset (sWASO) \>= 60 minutes on at least 3 nights over any 7-day period during Part 1 of screening, using the Consensus Sleep Diary - Morning Administration (CSD-M), prior to screening polysomnography (PSG) assessments
• Participant must demonstrate a 2-night mean latency to persistent sleep (LPS) of \>= 25 minutes (with neither night less than \[\<\] 20 minutes), a 2 night mean wake after sleep onset (WASO) \>= 30 minutes, and a 2 night mean total sleep time (TST) less than or equal to (=\<) 6.5 hours, with neither night greater than (\>) 7 hours
• Participant must be otherwise healthy or present with stable, well-controlled, chronic conditions on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening

You may not qualify if:

• Has uncontrolled hypertension (supine systolic blood pressure \>150 millimeter of mercury (mm Hg) in adult participants or \>160 mm Hg in elderly participants or supine diastolic blood pressure \>90 mm Hg, despite diet, exercise, or a stable dose of allowed antihypertensive therapy) at screening or Day 1. (A participant with hypertension may be included if the participant's hypertension has been controlled for at least 3 months prior to screening, and the dosage of any antihypertensive medication has been stable for the past 3 months)
• Has clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening. Participants with non-insulin dependent diabetes mellitus who are adequately controlled (hemoglobin A1c \[HbA1c\] =\< 8 percent \[%\]) may be eligible to participate if otherwise medically healthy. It is expected that laboratory values will generally be within the normal range, though minor deviations, which are not considered to be of clinical significance to both the investigator and the sponsor's Safety Physician, are acceptable
• Has clinically significant ECG abnormalities at screening or Day 1 prior to randomization defined as:
• QT interval corrected according to Fridericia's formula: \>= 450 millisecond (msec) (males); \>= 470 msec (females).
• Evidence of 2nd and 3rd degree atrioventricular block, or 1st degree atrioventricular block with PR interval \>210 msec, left bundle branch block.
• Features of new ischemia.
• Other clinically important arrhythmia
• Has significant hypersomnia not related to night time insomnia (based on clinical judgment of the investigator)
• Regularly naps more than 3 times per week
• Has a current diagnosis or recent history of psychotic disorder, major depressive disorder (MDD), bipolar disorder, or posttraumatic stress disorder, or other psychiatric condition that, in the investigator's opinion, would interfere with the participant's ability to participate in the trial
• Has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening or Day 1. Participants with a prior suicide attempt of any sort, or prior serious suicidal ideation/plan within the past 6 months, should be carefully screened for current suicidal ideation and only participants with non-serious items (1-3 of the suicidal ideation section of the C-SSRS) may be included at the discretion of the investigator
• Has insomnia related to restless leg syndrome (RLS) (defined as periodic leg movement \[PLM\]-arousal index of \>=10 PLM-related electroencephalograph (EEG) arousals per hour of sleep for adult participants or \>15 for elderly participants), sleep breathing disorder (defined as an apnea hypopnea index \>=10 cumulative apneas and hypopneas per hour of EEG sleep for adult participants or \>15 for elderly participants), or parasomnias. These disorders will be ruled out by the first PSG recording during Part 2 of screening
• Has known allergies, hypersensitivity, intolerance, lack of response, or any contraindication to JNJ-42847922 or zolpidem or their excipients
• Plans to father a child while enrolled in this study or within 3 months after the last dose of study drug; and/or, Is pregnant, or breastfeeding, while enrolled in this study or within 1 month after the last dose of study drug

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (56)

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

California Research Trials DBA Orange Country Research Institute

Anaheim, California, 92801, United States

Location

Excell Research Inc

Oceanside, California, 92056, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Empire Clinical Research, LLC

Upland, California, 91786, United States

Location

St. Francis Medical Institute

Clearwater, Florida, 33765-2103, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Sarkis Clinical Trials

Lake City, Florida, 32025, United States

Location

Innovative Clinical Research Inc

Lauderhill, Florida, 33319, United States

Location

Suncoast Research Group

Miami, Florida, 33135, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

NeuroTrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

Gastonia Medical Specialty Clinic

Gastonia, North Carolina, 28054, United States

Location

Clinical Research of Lake Norman

Mooresville, North Carolina, 28117, United States

Location

CTI Clinical Trial and Consulting Services

Cincinnati, Ohio, 45242, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Clinical Research of Charleston

Mt. Pleasant, South Carolina, 29464, United States

Location

FutureSearch Trials of Neurology, LP

Austin, Texas, 78731, United States

Location

Anima

Alken, 3570, Belgium

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Universiteit Antwerpen

Wilrijk, 2610, Belgium

Location

CHU de Grenoble Hopital Albert Michallon

Isere, 38043, France

Location

Hopital de La Croix Rousse

Lyon, 69004, France

Location

Hôpital Hôtel Dieu - Paris

Paris, 75181, France

Location

Centre Hospitalier Specialisé de Rouffach

Rouffach, 68250, France

Location

Advanced Sleep Research GmbH

Berlin, 10117, Germany

Location

Emovis GmbH

Berlin, 10629, Germany

Location

Synexus Clinical Research GmbH

Frankfurt, 60313, Germany

Location

CTC North GmbH & Co. KG

Hamburg, 20251, Germany

Location

Synexus Clinical Research GmbH

Sachsen, 04103, Germany

Location

Somni Bene GmbH

Schwerin, 19053, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

SOUSEIKAI PS Clinic

Fukuoka, 812-0025, Japan

Location

You Ariyoshi Sleep Clinic

Kitakyushu-shi, 802-0084, Japan

Location

Takedakai Kochi Kagamigawa Hospital

Kochi, 780-8037, Japan

Location

Kurume University Hospital

Kurume-shi, 830-0011, Japan

Location

National Hospital Organization Nagoya Medical Center

Nagoya, 460-0001, Japan

Location

Gokeikai Osaka Kaisei Hospital

Osaka, 532-0003, Japan

Location

Wellness Boyodai Hospital

Otaru-shi, 047-0155, Japan

Location

Suimin Sogo Care Clinic Yoyogi

Shibuya-ku, 151-0053, Japan

Location

Shinjuku Research Park Clinic

Shinjuku-ku, 169-0073, Japan

Location

Sekino Hospital

Toshima-ku, 171-0014, Japan

Location

Mie University Hospital

Tsu, 514-8507, Japan

Location

Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

Yokohama, 223-0059, Japan

Location

Centrum Badan Klinicznych PI House sp z o o

Gdansk, 80 546, Poland

Location

NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'

Katowice, 40-123, Poland

Location

Osrodek Badan Klinicznych CROMED

Poznan, 60-782, Poland

Location

EMC Instytut Medyczny SA

Wroclaw, 50 220, Poland

Location

Related Publications (1)

• Mesens S, Krystal AD, Melkote R, Xu H, Pandina G, Saoud JB, Luthringer R, Savitz A, Drevets WC. Efficacy and Safety of Seltorexant in Insomnia Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Aug 13;82(10):967-76. doi: 10.1001/jamapsychiatry.2025.1999. Online ahead of print.

  PMID: 40802194 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

seltorexant; Zolpidem

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Director Clinical Development
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 15, 2017
• Study Start: November 23, 2017
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: April 29, 2025
• Results First Posted: May 23, 2022

Record last verified: 2025-04

Locations

DE (7); PL (4); FR (4); JP (12); US (24); BE (5)