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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
2026-06-05
Healthy Volunteers
No
Conditions
Interventions
Tasimelteon Oral Suspension
Single daily dose, weight-based liquid suspension formulation.
Placebo
Placebo comparator.
Locations (35)
Vanda Investigational Site
Dothan, Alabama, United States
Vanda Investigational Site
Phoenix, Arizona, United States
Vanda Investigational Site
Irvine, California, United States
Vanda Investigational Site
Miami, Florida, United States
Vanda Investigational Site
Miami Lakes, Florida, United States
Vanda Investigational Site
Winter Park, Florida, United States
Vanda Investigational Site
Snellville, Georgia, United States
Vanda Investigational Site
Stockbridge, Georgia, United States
Vanda Investigational Site
Naperville, Illinois, United States
Vanda Investigational Site
Worcester, Massachusetts, United States
Vanda Investigational Site
Great Falls, Montana, United States
Vanda Investigational Site
Lincoln, Nebraska, United States
Vanda Investigational Site
Las Vegas, Nevada, United States
Vanda Investigational Site
Cleveland, Ohio, United States
Vanda Investigational Site
Columbia, South Carolina, United States
Vanda Investigational Site
Myrtle Beach, South Carolina, United States
Vanda Investigational Site
Nashville, Tennessee, United States
Vanda Investigational Site
Houston, Texas, United States
Vanda Investigational Site
Plano, Texas, United States
Vanda Investigational Site
San Antonio, Texas, United States
Vanda Investigational Site
San Antonio, Texas, United States
Vanda Investigational Site
Berlin, Germany
Vanda Investigational Site
Leipzig, Germany
Vanda Investigational Site
Bydgoszcz, Poland
Vanda Investigational Site
Gdansk, Poland
Vanda Investigational Site
Krakow, Poland
Vanda Investigational Site
Poznan, Poland
Vanda Investigational Site
Wroclaw, Poland
Vanda Investigational Site
Great Yarmouth, United Kingdom
Vanda Investigational Site
Leicester, United Kingdom
Vanda Investigational Site
Liverpool, United Kingdom
Vanda Investigational Site
London, United Kingdom
Vanda Investigational Site
London, United Kingdom
Vanda Investigational Site
London, United Kingdom
Vanda Investigational Site
Sheffield, United Kingdom