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.

Phase 2

Completed

• Conditions: 10040991; Insomnia

• Registration Number: NL-OMON42553
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

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 sleepdisorders. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Latency to persistent sleep (minutes)<br /><br>- Total sleep time (minutes)<br /><br>- Wake After Sleep Onset (minutes)<br /><br>- Wake during total sleep period (minutes)<br /><br>- Wake after final awakening (minutes)<br /><br>- Sleep efficiency (%)<br /><br>- Total time spent in deep sleep (duration of slow wave sleep) (minutes)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>PSG secondary endpoints<br /><br>- Time in bed (minutes)<br /><br>- Sleep onset latency (minutes)<br /><br>- Number of awakenings (#)<br /><br>- Time to first awakening after sleep onset (minutes)<br /><br>- REML (minutes)<br /><br>- Duration of REM sleep (minutes)<br /><br>- Duration of Stage 1 Sleep (minutes)<br /><br>- Duration of Stage 2 Sleep (minutes)<br /><br>- Number of REM blocs (#)<br /><br><br /><br>Safety<br /><br>- ECG<br /><br>- Vital signs<br /><br>- Blood chemistry / hematology<br /><br><br /><br>Suicidal assessment by C-SSRS Questionnaire<br /><br><br /><br>Sleep questionnaires:<br /><br>Bond and Lader Visual Analogue Scale<br /><br>Karolinska Sleepiness Scale<br /><br>Leeds Sleep Evaluation Questionnaire</p><br>