Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
RecruitingPhase 3
A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Who can join
Ages 2 to 17 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Tasimelteon Oral Suspension (drug)
- Placebo (drug)
Sponsor: Vanda Pharmaceuticals · Participants: 420 · Started: Apr 21, 2025
Contact the study team
- Vanda Pharmaceuticals, Inc. · Phone: 202-734-3400
Official record on ClinicalTrials.gov — NCT06953869
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.