A double-blind study to evaluate the efficacy and safety of JNJ-42847922 in subjects with insomnia disorder
- Conditions
- Insomnia DisorderMedDRA version: 20.0Level: LLTClassification code 10078083Term: Insomnia disorderSystem Organ Class: 100000004873Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-000980-33-FR
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 364
1. Subject must be a man or woman, 18 to 85 years of age, inclusive, on the day of signing informed consent. Note: Subjects should be at least 18 years of age or older as per the legal age of consent in the jurisdiction in which the study is taking place. For subjects =65 years of age, a Mini-Mental State Examination score of =25 to rule out cognitive impairment in the interest of subject safety.
2. Subject must meet DSM-5 criteria for insomnia disorder.
•A predominant complaint of dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
– Difficulty initiating sleep
– Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings
– Early-morning awakening with inability to return to sleep.
•The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.
•The sleep difficulty occurs at least 3 nights per week.
•The sleep difficulty is present for at least 3 months.
•The sleep difficulty occurs despite adequate opportunity for sleep.
•The insomnia is not better explained by and does not occur exclusively during the course of another sleep-wake disorder (eg, narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia).
•The insomnia is not attributable to the physiological effects of a substance (eg, a drug of abuse, a medication).
•Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.
3. Subject must have an ISI total score =15 at screening.
(Note: For subjects taking hypnotic drugs at the time of signing the informed consent form [ICF], administration of the ISI must occur at least 5 days after the last dose of all hypnotic drugs.)
4. Subject must have an sSOL =45 minutes and an sWASO =60 minutes on at least 3 nights over any 7-day period during Part 1 of screening, using the CSD-M, prior to screening PSG assessments.(Note: For subjects taking hypnotic drugs at the time of signing the ICF, administration of the CSD-M must start at least 5 days after the last dose of all hypnotic drugs.)
5. Subject must demonstrate a 2-night mean LPS of =25 minutes (with neither night <20 minutes), a 2-night mean WASO =30 minutes, and a 2-night mean TST =6.5 hours, with neither night >7 hours.
6. Before randomization, a woman must be either: Not of childbearing potential defined as: postmenopausal OR permanently sterile. Or of childbearing potential and practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) and agrees to remain on a highly effective method throughout the study and for at least 1 month after the last dose of study drug.
A woman using oral contraceptives must use an additional birth control method.
Note: If the childbearing potential changes after start of the study (eg, a premenarchal woman experiences menarche) or the risk of pregnancy changes (eg, a woman who is not heterosexually active becomes active) a woman must begin a highly effective method of contraception, as described throughout the inclusion criteria. (NOTE additional requirements and definitions for this incision criteria can be found within the protocol).
(Please refer to protocol for additional inclusion criteria)
Are the trial subjects under 18? no
Number of subjects for th
1. 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 mL/min]; serum creatinine >2 mg/dL); significant and/or unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, immunologic, or metabolic disturbances. Organic brain disease, epilepsy, dementia, and known or suspected mental retardation are exclusionary. Any clinically relevant medical condition that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study (eg, medically frail subject with history of hospitalization due to fractures) or could potentially alter the absorption, metabolism, or excretion of the study drug is
exclusionary.
2. Has uncontrolled hypertension (supine systolic blood pressure >150 mm Hg in adult subjects or >160 mm Hg in elderly subjects 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 subject with hypertension may be included if the subject’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).
3. Has clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening. Subjects with non-insulin dependent diabetes mellitus who are adequately controlled (hemoglobin A1c [HbA1c] =8%) 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.
4. Has clinically significant ECG abnormalities at screening or Day 1 prior to randomization defined as: QT interval corrected according to Fridericia’s formula: =450 msec (males); =470 msec (females). Evidence of 2nd and 3rd degree atrioventricular block, or 1st degree atrioventricular block with PR interval >200 msec, left bundle branch block. Features of new ischemia and other clinically important arrhythmia.
Note: Subjects with right bundle branch block may be allowed provided confirmation that right bundle branch block is not associated with underlying cardiac/lung diseases.
5. Has significant hypersomnia not related to night time insomnia (based on clinical judgment of the investigator).
6. 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 andintent) for ideation on the C-SSRS, or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening or Day 1. Subjects 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 subjects with non-serious items (1-3 of the suicidal ideation section of the C-SSRS) may be included at the discretion of the investigator.
7. Has insomnia related to RLS (defined as PLM-arousal index of =10 PLM-related electroencephalograph (EEG) arousals per hour of sleep for adult su
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method