drugset / Trial / NCT06953869

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

NCT06953869

Phase 3 Recruiting 420 enrolled Vanda Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-04-21
Primary completion
2027-11
Completion
2028-01

Drugs

EvaluationDrugModalityDoseRoute
Subject tasimelteon Small molecule Oral

Indications