A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day

A vizsgálat adatai

Ki végzi

Idorsia Pharmaceuticals Ltd.

Azonosító

NCT07843329EU 2026-525730-38-00

A regiszteradat frissítve

2026. november 5.

Eredeti leírás

The purpose of this clinical trial is to collect more data about the effect of daridorexant in adults and elderly people with insomnia disorder.A teljes eredeti leírásKevesebb

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy of Daridorexant on Nighttime Symptoms and Daytime Functioning in Adult and Elderly Participants With Insomnia Disorder

The purpose of this clinical trial is to collect more data about the effect of daridorexant in adults and elderly people with insomnia disorder.

The trial aims to find out whether daridorexant can help improve:

* how trial participants sleep at night, * how trial participants function the next day.

Researchers will compare daridorexant to a placebo (a look-alike inactive substance that contains no active medicine) to understand which effect daridorexant has on total sleep time and next-day functioning.

Enrolled participants will:

* Take daridorexant 50 mg or placebo once daily for approximately 3 months * Visit the clinic once every month during treatment for checkups and tests * Keep a sleep diary of the number of hours they sleep and how well they sleep * Complete a questionnaire every day about any symptoms of sleepiness during the day and any impact on physical and mental functioning such as energy levels, mood, or ability to concentrate or memorize.

Bevonási feltételek: Male or female participants aged ≥ 18 years at the time of signing the ICF; Insomnia disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders criteria including: Self-reported insufficient sleep quantity defined as subjective Total Sleep Time (TST) ≤ 6.5 hours during the night, associated with difficulties with sleep initiation or maintenance or early-morning awakenings, for at least 3 nights per week during a period of at least 3 months prior to screening visit; Insomnia Severity Index© score ≥ 15; Presence of insomnia symptoms (TST ≤ 6.5 hours for at least 3 valid nights recording, and average TST ≤ 6.5 hours over 7 nights) confirmed by objective measurements using a home electroencephalogram (EEG) device over a 7-night period during screening; Adequate opportunity for sleep (time in bed ≥ 7 hours for at least 3 valid recorded nights) confirmed by objective measurements obtained using the home EEG device during the 7-night assessment period specified in the inclusion criterion above.

Kizáró feltételek: Previous treatment with daridorexant or other dual orexin receptor antagonists at any time prior to Visit 1; Any lifetime history of breathing-related sleep disorder; Presence of an additional sleep-wake disorder; Acute or unstable (i.e., not adequately controlled for at least 1 month) psychiatric condition; Any suicidal ideation or history of suicide attempt, as assessed by Columbia Suicide Severity Rating Scale© (C-SSRS©), at Visit 1; Unstable medical condition, which, in the opinion of the investigator, could affect the participant's safety or interfere with the trial assessments; Body mass index < 18.5 or > 40.0 kg/m2; Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week.

ClinicalTrials.gov NCT07843329 · EU CTIS 2026-525730-38-00