Trial Profile

Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography, Dose-finding 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: Recruiting

Phase of Trial: Phase II

Latest Information Update: 11 Aug 2025

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At a glance

30 Jul 2025 According to the Idorsia Pharmaceuticals Media Release, The study is part of a US FDA-approved Pediatric Study Plan and an EU PDCO-approved Paediatric Investigation Plan.
30 Jul 2025 According to the Idorsia Pharmaceuticals Media Release, The study is expected to complete enrollment by the end of 2025 with readout expected around mid-2026.
07 May 2025 Planned End Date changed from 27 Apr 2025 to 1 Apr 2026.

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