Trials / Recruiting
RecruitingNCT06953869
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 420 (estimated)
- Sponsor
- Vanda Pharmaceuticals · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tasimelteon Oral Suspension | Single daily dose, weight-based liquid suspension formulation. |
| DRUG | Placebo | Placebo comparator. |
Timeline
- Start date
- 2025-04-21
- Primary completion
- 2027-11-01
- Completion
- 2028-01-01
- First posted
- 2025-05-01
- Last updated
- 2025-05-01
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06953869. Inclusion in this directory is not an endorsement.