RecruitingPhase 3NCT06953869

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

A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

Sponsor

Vanda Pharmaceuticals

Enrollment

420 participants

Start Date

Apr 21, 2025

Study Type

INTERVENTIONAL

Conditions

Insomnia Disorder

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.

Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Tasimelteon Oral Suspension for people with insomnia disorder. The study is currently recruiting participants at 35 locations. People eligible for this study include aged 2 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTasimelteon Oral Suspension

Single daily dose, weight-based liquid suspension formulation.

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT06953869

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