A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Vanda Pharmaceuticals
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
- Age range
- 2–17 years
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- DrugTasimelteon Oral Suspension
Single daily dose, weight-based liquid suspension formulation.
- DrugPlacebo
Placebo comparator.
Locations (3)
- Vanda Investigational SiteWinter Park, Florida
- Vanda Investigational SiteCharlotte, North Carolina
- Vanda Investigational SiteSan Antonio, Texas