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
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
Inclusion Criteria4
- 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 Criteria4
- 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.
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Interventions
DRUGTasimelteon Oral Suspension
Single daily dose, weight-based liquid suspension formulation.
DRUGPlacebo
Placebo comparator.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06953869
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