Clinical Trial

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/

Recruiting Phase 3

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Summary

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.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2025-04-23.

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