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

NCT ID: NCT03375203

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 365 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-23
• Study Completion Date: 2019-04-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

JNJ-42847922 5 milligram (mg)

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

Group Type: EXPERIMENTAL

JNJ-42847922, 5 mg

Intervention Type: DRUG

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

JNJ-42847922 10 mg plus Placebo

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

JNJ-42847922, 10 mg

Intervention Type: DRUG

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

JNJ-42847922 20 mg plus Placebo

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

JNJ-42847922, 20 mg

Intervention Type: DRUG

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

Zolpidem plus Placebo

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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

Zolpidem

Intervention Type: DRUG

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

Interventions

Placebo

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

Intervention Type: DRUG

JNJ-42847922, 5 mg

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

Intervention Type: DRUG

JNJ-42847922, 10 mg

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

Intervention Type: DRUG

JNJ-42847922, 20 mg

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

MIN-202; Seltorexant; MIN-202; Seltorexant; MIN-202; Seltorexant

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Has history of or current clinically significant and/or unstable liver (moderate or severe hepatic impairment [Child-Pugh Score {>=} 7]) or renal insufficiency (severe renal impairment [estimated creatinine clearance below 30 {milliliter per minute} mL/min]; serum creatinine >2 [milligram per deciliter] mg/dL); significant and/or unstable cardiac, vascular, pulmonary (example, acute or severe respiratory failure), gastrointestinal, endocrine, neurologic (example, myasthenia gravis, narcolepsy), hematologic, rheumatologic, immunologic, or metabolic disturbances. Organic brain disease, epilepsy, dementia, narcolepsy, narrow angle glaucoma and known or suspected mental retardation are exclusionary. Any clinically relevant medical condition that is likely to result in deterioration of the participant's condition or affect the participant's safety during the study (eg, medically frail participant with history of hospitalization due to fractures) or could potentially alter the absorption, metabolism, or excretion of the study drug is exclusionary
• 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:

1. QT interval corrected according to Fridericia's formula: >= 450 millisecond (msec) (males); >= 470 msec (females).

2. Evidence of 2nd and 3rd degree atrioventricular block, or 1st degree atrioventricular block with PR interval >210 msec, left bundle branch block.

3. Features of new ischemia.

4. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Preferred Research Partners

Little Rock, Arkansas, United States

Woodland Research Northwest

Rogers, Arkansas, United States

California Research Trials DBA Orange Country Research Institute

Anaheim, California, United States

Excell Research Inc

Oceanside, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Empire Clinical Research, LLC

Upland, California, United States

St. Francis Medical Institute

Clearwater, Florida, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Sarkis Clinical Trials

Lake City, Florida, United States

Innovative Clinical Research Inc

Lauderhill, Florida, United States

Suncoast Research Group

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

NeuroTrials Research, Inc.

Atlanta, Georgia, United States

Chicago Research Center

Chicago, Illinois, United States

Centennial Medical Group

Elkridge, Maryland, United States

Clinical Research Center of Nevada

Las Vegas, Nevada, United States

Gastonia Medical Specialty Clinic

Gastonia, North Carolina, United States

Clinical Research of Lake Norman

Mooresville, North Carolina, United States

CTI Clinical Trial and Consulting Services

Cincinnati, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Clinical Research of Charleston

Mt. Pleasant, South Carolina, United States

FutureSearch Trials of Neurology, LP

Austin, Texas, United States

Anima

Alken, , Belgium

Cliniques Universitaires Saint Luc

Brussels, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

UZ Leuven Gasthuisberg

Leuven, , Belgium

Universiteit Antwerpen

Wilrijk, , Belgium

CHU de Grenoble Hopital Albert Michallon

Isere, , France

Hopital de La Croix Rousse

Lyon, , France

Hôpital Hôtel Dieu - Paris

Paris, , France

Centre Hospitalier Specialisé de Rouffach

Rouffach, , France

Advanced Sleep Research GmbH

Berlin, , Germany

Emovis GmbH

Berlin, , Germany

Synexus Clinical Research GmbH

Frankfurt, , Germany

CTC North GmbH & Co. KG

Hamburg, , Germany

Synexus Clinical Research GmbH

Sachsen, , Germany

Somni Bene GmbH

Schwerin, , Germany

Klinische Forschung Schwerin GmbH

Schwerin, , Germany

SOUSEIKAI PS Clinic

Fukuoka, , Japan

You Ariyoshi Sleep Clinic

Kitakyushu-shi, , Japan

Takedakai Kochi Kagamigawa Hospital

Kochi, , Japan

Kurume University Hospital

Kurume-shi, , Japan

National Hospital Organization Nagoya Medical Center

Nagoya, , Japan

Gokeikai Osaka Kaisei Hospital

Osaka, , Japan

Wellness Boyodai Hospital

Otaru-shi, , Japan

Suimin Sogo Care Clinic Yoyogi

Shibuya-ku, , Japan

Shinjuku Research Park Clinic

Shinjuku-ku, , Japan

Sekino Hospital

Toshima-ku, , Japan

Mie University Hospital

Tsu, , Japan

Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

Yokohama, , Japan

Centrum Badan Klinicznych PI House sp z o o

Gdansk, , Poland

NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'

Katowice, , Poland

Osrodek Badan Klinicznych CROMED

Poznan, , Poland

EMC Instytut Medyczny SA

Wroclaw, , Poland

Countries

United States; Belgium; France; Germany; Japan; Poland

References

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.

Reference Type: DERIVED

PMID: 40802194 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

42847922ISM2005

Identifier Type: OTHER

Identifier Source: secondary_id

2017-000980-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108427

Identifier Type: -

Identifier Source: org_study_id