Evaluating Tasimelteon for Pediatric Insomnia
A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
This study is testing if a new sleep medication called tasimelteon can help children and teenagers aged 2 to 17 with insomnia sleep better compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Vanda Pharmaceuticals Industry-sponsored |
| Locations | 3 sites (Winter Park, Florida and 2 other locations) |
| Trial ID | NCT06953869 on ClinicalTrials.gov |
What this trial studies
This multicenter, double-blind, randomized study aims to assess the efficacy and safety of a daily oral dose of tasimelteon compared to a placebo in treating insomnia disorder in pediatric patients. Participants aged 2 to 17 years will be enrolled, and the study will monitor their response to the treatment over a specified period. The study is designed to ensure that the sleep disturbances are not caused by other medications, focusing solely on the effects of tasimelteon.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 2 to 17 years with a confirmed diagnosis of insomnia disorder.
Not a fit: Patients with impaired liver function, those who are pregnant or lactating, or those with a history of intolerance to tasimelteon may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and overall well-being in children suffering from insomnia.
How similar studies have performed: Previous studies have shown promise in using melatonin receptor agonists for sleep disorders, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Winter Park, Florida and 2 other locations
- Vanda Investigational Site — Winter Park, Florida, United States (Recruiting)
- Vanda Investigational Site — Charlotte, North Carolina, United States (Recruiting)
- Vanda Investigational Site — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Vanda Pharmaceuticals, Inc.
- Email: VEC162@vandapharma.com
- Phone: 202-734-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.