Multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography, dosefinding study assessing the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to < 18 years with insomnia disorder

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513885-20-00

Acronym

ID-078A205

Enrollment

Registered

2024-10-31

Start date

2022-12-05

Completion date

Unknown

Last updated

2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia Disorder

Brief summary

Change from baseline to Day 1 in TST (in min) as measured by polysomnography (PSG). PSG will be performed on 2 nights during the screening period and on Day 1 of the treatment period (total time frame: 3 days). Baseline is defined as the mean of the 2 PSG nights during the screening period.

Interventions

DRUGDaridorexant matching placebo

DRUGQUVIVIQ 50 mg film-coated tablets

DRUGQUVIVIQ 25 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline to Day 1 in TST (in min) as measured by polysomnography (PSG). PSG will be performed on 2 nights during the screening period and on Day 1 of the treatment period (total time frame: 3 days). Baseline is defined as the mean of the 2 PSG nights during the screening period.	—

Countries

Bulgaria, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026

Multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography, dosefinding study assessing the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to < 18 years with insomnia disorder