RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-21
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06953869

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.

Ages Eligible for Study:2 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
  2. * Confirmed clinical diagnosis of insomnia disorder
  3. * Males and Females between 2 and 17 years, inclusive.
  4. * The sleep disturbance must not be a result of another medication.
  1. * Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
  2. * Indication of impaired liver function.
  3. * Pregnant or lactating females.
  4. * A positive test for drugs of abuse.

Contacts and Locations

Study Contact

Vanda Pharmaceuticals, Inc.
CONTACT
202-734-3400
VEC162@vandapharma.com

Study Locations (Sites)

Vanda Investigational Site
Winter Park, Florida, 32789
United States
Vanda Investigational Site
Charlotte, North Carolina, 28277
United States
Vanda Investigational Site
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Vanda Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-21
Study Completion Date2028-01

Study Record Updates

Study Start Date2025-04-21
Study Completion Date2028-01

Terms related to this study

Additional Relevant MeSH Terms

  • Insomnia Disorder