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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03375203
Recruitment Status : Completed
First Posted : December 15, 2017
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Insomnia Disorders Drug: Placebo Drug: JNJ-42847922, 5 mg Drug: JNJ-42847922, 10 mg Drug: JNJ-42847922, 20 mg Drug: Zolpidem Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 23, 2017
Actual Primary Completion Date : April 3, 2019
Actual Study Completion Date : April 3, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Zolpidem

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants will receive matching placebo to JNJ-42847922 as oral capsules at normal study bedtime on Nights 1 through 14.
Drug: Placebo
Placebo (matching to JNJ-42847922 or Zolpidem) will be administered as one or two oral capsules once daily based upon dosing group.

Experimental: 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.
Drug: JNJ-42847922, 5 mg
JNJ-42847922 will be administered as 5 mg (2*2.5 mg capsule) oral capsules once daily.
Other Names:
  • MIN-202;
  • Seltorexant

Experimental: JNJ-42847922 10 mg
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
Placebo (matching to JNJ-42847922 or Zolpidem) will be administered as one or two oral capsules once daily based upon dosing group.

Drug: JNJ-42847922, 10 mg
JNJ-42847922 will be administered as 10 mg oral capsule once daily.
Other Names:
  • MIN-202;
  • Seltorexant

Experimental: JNJ-42847922 20 mg
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
Placebo (matching to JNJ-42847922 or Zolpidem) will be administered as one or two oral capsules once daily based upon dosing group.

Drug: JNJ-42847922, 20 mg
JNJ-42847922 will be administered as 20 mg oral capsule once daily.
Other Names:
  • MIN-202;
  • Seltorexant

Experimental: Zolpidem
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
Placebo (matching to JNJ-42847922 or Zolpidem) will be administered as one or two oral capsules once daily based upon dosing group.

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.




Primary Outcome Measures :
  1. Change from Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 [ Time Frame: Baseline, Night 1 ]
    LPS will be 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 scored as sleep.


Secondary Outcome Measures :
  1. Change from Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 [ Time Frame: Baseline, Night 1 ]
    WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (that is, 10 consecutive minutes of sleep) over the first 6 hours of PSG assessment.

  2. Change from Baseline in LPS on Night 13 of JNJ-42847922 Compared with Placebo [ Time Frame: Baseline, Night 13 ]
    LPS will be measured on Night 13 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch scored as sleep.

  3. Change from Baseline in WASO Over the First 6 Hours on Night 13 of JNJ-42847922 Compared with Placebo [ Time Frame: Baseline, Night 13 ]
    WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (that is, 10 consecutive minutes of sleep) over the first 6 hours of PSG assessment.

  4. Change from Baseline in Total Sleep Time (TST) on Nights 1 and 13 of JNJ-42847922 Compared with Placebo and Zolpidem [ Time Frame: Baseline, Nights 1 and 13 ]
    All of the hours of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.

  5. Change from Baseline in Sleep Efficiency (SE) on Nights 1 and 13 of JNJ-42847922 Compared with Placebo and Zolpidem [ Time Frame: Baseline, Nights 1 and 13 ]
    Sleep efficiency will be measured as the total sleep time divided by the total time in bed (that is, the number of hours from the beginning of the Polysomnography recording to the end of the recording).

  6. Change from Baseline in LPS on Nights 1 and 13 of JNJ-42847922 Compared with Zolpidem [ Time Frame: Baseline, Nights 1 and 13 ]
    LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch scored as sleep.

  7. Change from Baseline in WASO Over the First 6 Hours on Nights 1 and 13 of JNJ-42847922 Compared with Zolpidem [ Time Frame: Baseline, Nights 1 and 13 ]
    WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (that is, 10 consecutive minutes of sleep) over the first 6 hours to the end of PSG assessment the following morning.

  8. Change from Baseline in Subjective Sleep Parameters as Measured by the Consensus Sleep Diary - Morning Administration (CSD-M), in the Morning on Days 2 and 14 [ Time Frame: Baseline, Days 2 and 14 ]
    The CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. It allows for calculation of total time spent in bed and SE as the percentage of time asleep out of amount of time spent in bed. Sleep quality and how well rested participants felt at awaking are rated on a 5-point Likert scale ranging from "very poor" to "very good". Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep.

  9. Change from Baseline in Sleep Disturbance and Impairment as Measured by the National Institutes of Health Patient Reported Outcome Measurement Information System (PROMIS) on Days 8 and 14 [ Time Frame: Baseline, Days 8 and 14 ]
    Sleep disturbance and impairment will be measured by PROMIS Sleep Disturbance (PROMIS-SD) and PROMIS for Sleep Related Impairment (PROMIS SRI). PROMIS-SD and PROMIS-SRI subscales consist of 8 item questionnaires and use Five-point Likert scales to capture the participant's impressions. Using recall period of past 7 days, PROMIS-SD assesses the concepts of sleep initiation, quality of sleep, early morning feelings and worrying about sleep. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of 8 item scores are first synchronized prior to calculation of total raw score. In PROMIS-SRI scale, each item is based on 7 day recall period and assessed on a 5 score for with all questions answered, sum the values of response to each question. Example, for adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40.

  10. Change from Baseline in Participant's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale on Day 14 [ Time Frame: Baseline, Day 14 ]
    The PGI-S is a self-report scale to measure severity of illness (1=no insomnia, 2=very mild, 3=mild, 4=moderate, 5=severe, 6=very severe). Considering all aspects of insomnia, participants will rate their severity on the PGI-S.

  11. Participant's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale on Day 14 [ Time Frame: Day 14 ]
    The PGI-I is a self-report scale to measure improvement in illness (1=very much improved, 2=much improved, 3=improved [just enough to make a difference], 4=no change, 5=worse [just enough to make a difference], 6=much worse, 7=very much worse).

  12. Percentage of Responders, Defined as a >=50 Percent (%) Reduction from Baseline in Total Score on the Insomnia Severity Index (ISI) on Day 14 [ Time Frame: Day 14 ]
    The ISI is a 7-item questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. A 5-point Likert scale (0-4) is used to rate each item, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

  13. Percentage of Participants with Remission of Insomnia Symptoms, Defined as a Total Score <=10 on the ISI on Day 14 [ Time Frame: Day 14 ]
    Participants with a total score of less than or equal to (<=) 10 on the ISI scale will be reported. ISI is a 7-item questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. A 5-point Likert scale (0-4) is used to rate each item, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

  14. Change from Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) on Day 14 [ Time Frame: Baseline, Day 14 ]
    The CGI-S is a 7-point scale to measure severity of illness (1=normal [not at all ill], 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients). Higher score indicates more severity.

  15. Participant's Assessment of Improvement in Insomnia Using the Clinical Global Impression-Improvement (CGI-I) on Day 14 [ Time Frame: Day 14 ]
    The CGI-I is a 7-point scale to measure improvement in illness (1=very much improved, 2=much improved, 3=minimally improved, 4=no change from baseline, 5=minimally worse, 6=much worse, 7=very much worse). Higher score indicates more severity.

  16. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: From Screening, up to Day 24 ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  17. Number of Participants with Serious Adverse Events (SAEs) and Events of Special Interest [ Time Frame: From Screening, up to Day 24 ]
    An SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. All SAEs and events of special interest including parasomnias, cataplexy-like symptoms (sudden, transient episode of muscle weakness accompanied by conscious awareness) and sleep paralysis (when falling asleep/awakening the experience of not being able to move, react or speak), falls will be reported.

  18. Participant's Suicidality Ideation Assessed Using C-SSRS [ Time Frame: Baseline, Day 14 ]
    C-SSRS is a clinician rated assessment of suicidal behavior and/or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.

  19. Next-Day Residual Effect Measured by the Karolinska Sleepiness Scale (KSS) on Days 2 and 14 [ Time Frame: Baseline, Days 2 and 14 ]
    The KSS is a patient reported assessment of level of drowsiness at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in measuring sleepiness. It consists of a 9-point Likert scale with response options from: 1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep).

  20. Next-Day Residual Effects Measured by Postural Stability (Body Sway) [ Time Frame: Baseline, Morning: Days 2 and 14; 4 Hours Post Night 14 Dose (Day 15) ]
    The body sway meter allows measurement of body movements in a single plane, providing a measure of postural stability. Body sway is measured using an Ataxia meter.

  21. Change in Cognition Compared to Pre-dose Assessment on Objective Cognitive Assessment as Measured by a Computerized Battery of Cognitive Tests in the Morning on Days 2 and 14 [ Time Frame: Baseline, Days 2 and 14; 4 Hours Post Night 14 Dose (Day 15) ]
    Cognitive assessment objectively will be measured by a computerized battery of cognitive tests.

  22. Cognitive Performance on Day 15 at 4-Hours Post Night 14 Dose (Middle of the Night Awakening) as Measured by a Computerized Battery of Cognitive Tests [ Time Frame: 4-Hours Post Night 14 Dose (Day 15) ]
    Cognitive performance will be assessed with middle of the night awakening (4 hours after dose) on Night 14 with the computerized cognitive battery and ataxia meter.

  23. Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the CSD-M [ Time Frame: Day 14 and Day 17 ]
    The CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. It allows for calculation of total time spent in bed and SE as the percentage of time asleep out of amount of time spent in bed. Sleep quality and how well rested participants felt at awaking are rated on a 5-point Likert scale ranging from "very poor" to "very good". Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep.

  24. Change in Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 [ Time Frame: Day 14 to Day 17 ]
    The Physician Withdrawal Checklist (20 items; PWC-20) is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition.

  25. Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) for Self-Assessment of Withdrawal Symptoms on Day 17 [ Time Frame: Day 17 ]
    The BWSQ is a 20 symptom self-report questionnaire to investigate withdrawal symptoms. Participants rate the degree to which they are experiencing each symptom as either "No," "Yes-moderate" or "Yes-severe". The questionnaire has been shown to be reliable and to have acceptable construct validity in assessing withdrawal symptoms.

  26. Number of Participants With Clinically Significant Vital Signs Abnormalities [ Time Frame: From Screening, up to Day 24 ]
    Vital signs including temperature, pulse/heart rate, respiratory rate and blood pressure will be assessed.

  27. Number of Participants With Clinically Significant Physical Examination Abnormalities [ Time Frame: From Screening, up to Day 24 ]
    Physical examination including examination of height, body weight, and waist circumference will be assessed.

  28. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities [ Time Frame: From Screening, up to Day 24 ]
    A 12-lead ECG will be performed.

  29. Number of Participants With Clinically Significant Laboratory Abnormalities [ Time Frame: From Screening, up to Day 24 ]
    Blood samples for serum chemistry, hematology, and urinalysis will be collected for clinical laboratory testing.

  30. Maximum Observed Plasma Concentration (Cmax) of JNJ-42847922 and its Metabolites [ Time Frame: Night 2/Day 3: predose, 30min, 1 hour(h), 2h, 3h, 6h,12h ]
    The Cmax is the maximum observed plasma concentration and will be determined for JNJ-42847922 and its Metabolites (M12 and M16).

  31. Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-42847922 and its Metabolites [ Time Frame: Night 2/Day 3: predose, 30min, 1 hour(h), 2h, 3h, 6h,12h ]
    Tmax is defined as time to reach the maximum observed plasma concentration and will be determined for JNJ-42847922 and its Metabolites (M12 and M16).

  32. Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours Post-dose (AUC[0-12]h) [ Time Frame: Night 2/Day 3: predose, 30min, 1 hour(h), 2h, 3h, 6h,12h ]
    The AUC ([0-12]h) is the area under the plasma concentration-time curve from time zero to 12 hours post dose and will be determined for JNJ-42847922 and its Metabolites (M12 and M16).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375203


  Show 56 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03375203     History of Changes
Other Study ID Numbers: CR108427
42847922ISM2005 ( Other Identifier: Janssen Research & Development, LLC )
2017-000980-33 ( EudraCT Number )
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Zolpidem
Disease
Sleep Initiation and Maintenance Disorders
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action