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NCT06953869PHASE3Recruiting

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

Vanda Pharmaceuticals

Start Date

4/21/2025

Completion Date

1/1/2028

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 Criteria

Age Range: 2 years to 17 years

Inclusion Criteria: * Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required). * Confirmed clinical diagnosis of insomnia disorder * Males and Females between 2 and 17 years, inclusive. * The sleep disturbance must not be a result of another medication. Exclusion Criteria: * Inability to dose daily with tasimelteon or previous intolerance to tasimelteon. * Indication of impaired liver function. * Pregnant or lactating females. * A positive test for drugs of abuse.

Interventions

DRUG

Tasimelteon Oral Suspension

DRUG

Placebo

Interested in This Trial?

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Conditions

Insomnia Disorder

Locations

Vanda Investigational Site

Dothan, Alabama 36303

United States

Vanda Investigational Site

Phoenix, Arizona 85006

United States

Vanda Investigational Site

Irvine, California 92614

United States

Vanda Investigational Site

Miami, Florida 33155

United States

Vanda Investigational Site

Miami Lakes, Florida 33016

United States

Vanda Investigational Site

Winter Park, Florida 32789

United States

Vanda Investigational Site

Snellville, Georgia 30078

United States

Vanda Investigational Site

Stockbridge, Georgia 30281

United States

Vanda Investigational Site

Naperville, Illinois 60563

United States

Vanda Investigational Site

Worcester, Massachusetts 01608

United States

Vanda Investigational Site

Great Falls, Montana 59405

United States

Vanda Investigational Site

Lincoln, Nebraska 68526

United States

Vanda Investigational Site

Las Vegas, Nevada 89128

United States

Vanda Investigational Site

Cleveland, Ohio 11100

United States

Vanda Investigational Site

Columbia, South Carolina 29201

United States

Vanda Investigational Site

Myrtle Beach, South Carolina 29582

United States

Vanda Investigational Site

Nashville, Tennessee 37232

United States

Vanda Investigational Site

Houston, Texas 77030

United States

Vanda Investigational Site

Plano, Texas 75075

United States

Vanda Investigational Site

San Antonio, Texas 78229

United States

Vanda Investigational Site

San Antonio, Texas 78249

United States

Vanda Investigational Site

Berlin, 10117

Germany

Vanda Investigational Site

Leipzig, 04177

Germany

Vanda Investigational Site

Bydgoszcz, 85-092

Poland

Vanda Investigational Site

Gdansk, 80-546

Poland

Vanda Investigational Site

Krakow, 30-721

Poland

Vanda Investigational Site

Poznan, 60-848

Poland

Vanda Investigational Site

Wroclaw, 50-414

Poland

Vanda Investigational Site

Great Yarmouth, NR31 6LA

United Kingdom

Vanda Investigational Site

Leicester, LE1 5WW

United Kingdom

Vanda Investigational Site

Liverpool, L12 2AP

United Kingdom

Vanda Investigational Site

London, E1 1FR

United Kingdom

Vanda Investigational Site

London, SE1 7EH

United Kingdom

Vanda Investigational Site

London, SE6 4LF

United Kingdom

Vanda Investigational Site

Sheffield, S10 2TH

United Kingdom