Trial intelligence / Profile preview

Daridorexant in pediatric insomnia disorder

NCT05423717Phase 2

Key facts

Status
Completed
Start
Sep 2022
Primary completion
Jan 2026
Countries
6
Sponsor
Idorsia
Modality
Small Molecules
Conditions
insomnia disorder
01

Overview

Phase 2, randomised, double-blind trial of daridorexant in insomnia disorder (4 arms), sponsored by Idorsia. Primary endpoint: Total Sleep Time at Day 1. Started Sep 2022; status: completed.

02

Design

4 arms
Study design
RandomizedDouble-blind
  • Daridorexant 10 mg

  • Daridorexant 25 mg

  • Daridorexant 50 mg

  • Placebo

03

Who it enrols

Pediatric subjects (10-17 years) with chronic insomnia disorder (ICSD-3 or DSM-5) for at least 3 months, weighing at least 25 kg, and without other sleep-wake disorders or significant unstable medical conditions.

04

Endpoints

Primary

  • Total Sleep Time

05

Results

Primary endpoints met

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