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

Description

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.

Conditions

Insomnia Disorder

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Insomnia Disorder
Intervention / Treatment

-

Contacts and Locations

Winter Park

Vanda Investigational Site, Winter Park, Florida, United States, 32789

Charlotte

Vanda Investigational Site, Charlotte, North Carolina, United States, 28277

San Antonio

Vanda Investigational Site, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanda Pharmaceuticals,

Study Record Dates

2028-01