NCT06953869 Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
| NCT ID | NCT06953869 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vanda Pharmaceuticals |
| Condition | Insomnia Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2025-04-21 |
| Primary Completion | 2027-11 |
Trial Parameters
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Brief 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
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.
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