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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 420 participants in total. It began in 2025-04-21 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06953869 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Insomnia Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06953869 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 420 participants.
Is NCT06953869 currently recruiting?
Yes, NCT06953869 is actively recruiting participants. Contact the research team at VEC162@vandapharma.com for enrollment information.
Where is the NCT06953869 trial being conducted?
This trial is being conducted at Dothan, United States, Phoenix, United States, Irvine, United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT06953869 clinical trial?
NCT06953869 is sponsored by Vanda Pharmaceuticals. The trial plans to enroll 420 participants.
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