Clinical trial NCT02464046: Study to Evaluate Efficacy, Safety and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder Without Psychiatric Comorbidity
Official title: A Randomized, Placebo-controlled, 2-way Crossover, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-42847922 in Subjects With Insomnia Disorder Without Psychiatric Comorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia
Keywords: Insomnia
JNJ-42847922
Placebo
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-06-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: This is a multi-center, randomized (study medication assigned to participants by chance), placebo-controlled, double-blind (neither physician nor participant knows the identity of the assigned treatment), 2-way cross-over study of JNJ-42847922 participants with insomnia disorder without psychiatric comorbidity. The study consists of following phases: screening (28 days prior to Day 1), a double-blind treatment phase (consists of 5-day treatments, either JNJ-42847922 or placebo in subsequent 2-treatment periods, each separated with washout period of 5 to 9 days), and a follow-up examination (7 to 14 days after last dose administration). Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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
* Insomnia: at screening participants will report both difficulties with sleep onset and sleep maintenance. Insomnia will furthermore objectively be established prior to enrollment per PSG recorded over 3 consecutive nights. Participants will sleep for 3 consecutive nights in the sleep center. First and second night data will be used to exclude any participant with restless leg syndrome, apnea, parasomnias or other sleep disorders. On the second and third night participants are required to meet objective inclusion criteria: 2-night mean LPS of \>=30 minutes with no night \<20 minutes, and on both nights TST \<=6 hours and wake after sleep onset (WASO) \>30 minutes
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sleep Efficiency by Polysomnography
timeFrame: up to Night 5
Secondary outcomes:
measure: Total Sleep Time by Polysomnography
timeFrame: up to Night 5
measure: Wake Time After Sleep Onset by Polysomnography
timeFrame: up to Night 5
measure: Number of Awakenings After Persistent Sleep by Polysomnography
timeFrame: up to Night 5
measure: Total Time Spent in Deep Sleep by Polysomnography
timeFrame: up to Night 5
measure: Mean Latency to Persistent Sleep by Polysomnography
timeFrame: up to Night 5
measure: Leeds Sleep Evaluation Questionnaire (LSEQ) Score
timeFrame: up to Night 5
measure: Subjective assessment of sleep by Questionnaire
timeFrame: up to Night 5
measure: Next Morning Residual Effects by Bond and Lader Visual Analogue Scale
timeFrame: up to Night 5
measure: Next Morning Residual Effects by cognitive test battery
timeFrame: up to Night 5
measure: Next Morning Residual Effects by Karolinska Sleepiness Scale
timeFrame: up to Night 5
measure: Number of Participants with Adverse Events (AEs) and Serious AEs
timeFrame: up to Night 5
Other outcomes:
Locations:
city: Hollywood
country: United States
state: Florida
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Schwerin
country: Germany
city: Leiden
country: Netherlands
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical trial
role: STUDY_DIRECTOR
References:
citation: 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.