Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Public ClinicalTrials.gov record NCT06953869. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06953869
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 420 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 20, 2025
- Primary completion
- Oct 31, 2027
- Completion
- Dec 31, 2027
- Last update posted
- Jun 4, 2026
2025 – 2028
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Vanda Investigational Site | Dothan | Alabama | 36303 | Recruiting |
| Vanda Investigational Site | Phoenix | Arizona | 85006 | Recruiting |
| Vanda Investigational Site | Irvine | California | 92614 | Recruiting |
| Vanda Investigational Site | Miami | Florida | 33155 | Recruiting |
| Vanda Investigational Site | Miami Lakes | Florida | 33016 | Recruiting |
| Vanda Investigational Site | Winter Park | Florida | 32789 | Recruiting |
| Vanda Investigational Site | Snellville | Georgia | 30078 | Recruiting |
| Vanda Investigational Site | Stockbridge | Georgia | 30281 | Recruiting |
| Vanda Investigational Site | Naperville | Illinois | 60563 | Recruiting |
| Vanda Investigational Site | Worcester | Massachusetts | 01608 | Recruiting |
| Vanda Investigational Site | Great Falls | Montana | 59405 | Recruiting |
| Vanda Investigational Site | Lincoln | Nebraska | 68526 | Active, not recruiting |
| Vanda Investigational Site | Las Vegas | Nevada | 89128 | Recruiting |
| Vanda Investigational Site | Cleveland | Ohio | 11100 | Recruiting |
| Vanda Investigational Site | Columbia | South Carolina | 29201 | Recruiting |
| Vanda Investigational Site | Myrtle Beach | South Carolina | 29582 | Recruiting |
| Vanda Investigational Site | Nashville | Tennessee | 37232 | Recruiting |
| Vanda Investigational Site | Houston | Texas | 77030 | Recruiting |
| Vanda Investigational Site | Plano | Texas | 75075 | Recruiting |
| Vanda Investigational Site | San Antonio | Texas | 78229 | Recruiting |
| Vanda Investigational Site | San Antonio | Texas | 78249 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06953869, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06953869 live on ClinicalTrials.gov.