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Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

Name: Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia — clinical trial record (NCT06953869)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorVanda Pharmaceuticals

Started2025-04-21

View on ClinicalTrials.gov ↗

Amendment history

2026-06-03

Study Status, Oversight, Contacts/Locations v1

Study sites3→35

2025-04-23

Original filing

Vanda Pharmaceuticals

23 trials monitored

See 3 trials at risk

This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.

Trial Details

NCT Number	NCT06953869
Lead Sponsor	Vanda Pharmaceuticals
Conditions	Insomnia Disorder
Enrollment	420 participants
Start Date	2025-04-21
Primary Completion	2027-11 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-05