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Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Sponsor: Vanda Pharmaceuticals
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.
Official title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2025-04-21
Completion Date
2028-01
Last Updated
2025-05-01
Healthy Volunteers
No
Conditions
Interventions
Tasimelteon Oral Suspension
Single daily dose, weight-based liquid suspension formulation.
Placebo
Placebo comparator.
Locations (3)
Vanda Investigational Site
Winter Park, Florida, United States
Vanda Investigational Site
Charlotte, North Carolina, United States
Vanda Investigational Site
San Antonio, Texas, United States