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NCT06953869 · ClinicalTrials.gov registry record · Phase 3
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
A Phase 3 study of Insomnia Disorder, sponsored by Vanda Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 420
- Enrollment target
- 3
- Study locations
NCT06953869: Recruiting Phase 3 study of Insomnia Disorder, sponsored by Vanda Pharmaceuticals.
NCT06953869 is a Phase 3 study of Insomnia Disorder that is actively recruiting participants, run by Vanda Pharmaceuticals. The registered enrollment target is 420 participants, roughly in line with the 423-participant average among 8 other Insomnia Disorder trials with a reported enrollment target. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06953869, a Phase 3 study of Insomnia Disorder, is actively recruiting participants, sponsored by Vanda Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 420 participants
- Enrollment target
- 3
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG Tasimelteon Oral Suspension
Study Locations (3)
Florida
- Vanda Investigational Site - Winter Park
North Carolina
- Vanda Investigational Site - Charlotte
Texas
- Vanda Investigational Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2025-04-21 |
| Est. Completion | 2028-01 |
| Phase | Phase 3 |
What NCT06953869 shows while recruiting
NCT06953869 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 423-participant average among 8 other Insomnia Disorder trials with a reported enrollment target.
The record links to 1 condition, with Insomnia Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06953869 reports a single indexed study location in Florida, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT06953869 about?
NCT06953869 is a clinical study titled "Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia". 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.
What is the current status of trial NCT06953869?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2025-04-21. Estimated completion is 2028-01.
What conditions does trial NCT06953869 study?
This clinical trial studies the following conditions: Insomnia Disorder.
What interventions are being tested in trial NCT06953869?
The interventions under investigation include: Placebo (DRUG), Tasimelteon Oral Suspension (DRUG).
Who is sponsoring clinical trial NCT06953869?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06953869 being conducted?
This trial has 3 study locations across Florida, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insomnia Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06953869's enrollment target sits among peer trials
420 3rd of 8 higher than 6 of 8 other Insomnia Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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-
Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study
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