CompletedPhase 2

Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder

United States166 participantsStarted 2022-09-06

Plain-language summary

This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to \< 18 years with insomnia disorder.

Who can participate

Age range10 Years – 17 Years

SexALL

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Inclusion criteria

✓. Difficulty initiating or maintaining sleep, or early morning awakening with inability to return to sleep,
✓. Sleep difficulty has been present for at least 3 months prior to Screening,
✓. Sleep difficulty occurs at least 3 nights per week,
✓. Persistence of sleep difficulty, despite adequate sleep hygiene or non-pharmacological therapy,
✓. The sleep problem occurs despite adequate age appropriate time and opportunity for sleep,
✓. The sleep problem is not due to the direct pharmacological effects of any concomitant medication (e.g., amphetamines, selective serotonin reuptake inhibitors) as per investigator judgment,
✓. Self-report or caregiver report of poor sleep quality and/or quantity impacting the daytime performance of the subject,
✓. Negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization.

Exclusion criteria

✕. Any suicidal ideation with intent, with or without a plan at Screening, i.e., answering "Yes" to questions 4 or 5 on the suicidal ideation section of the lifetime (Visit 1) and visit (Visit 2) version of the Columbia Suicide Severity Rating Scale© (C-SSRS©). Participants who answer "yes" to any of these questions must be referred to the investigator for follow-up evaluation.
✕. History of suicide attempt on the suicidal behavior section of the lifetime version of the C-SSRS© at Visit 1.

What they're measuring

Change from baseline to Day 1 in Total Sleep Time (TST) as measured by polysomnography (PSG).

Timeframe: PSG will be performed on 2 nights during the screening period and on Day 1 of the treatment period (total duration: 3 days).

Trial details

NCT IDNCT05423717

SponsorIdorsia Pharmaceuticals Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-12

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