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NCT05361707 · ClinicalTrials.gov registry record · Phase 3
Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
A Phase 3 study of Autism Spectrum Disorder and Sleep Disturbance, sponsored by Vanda Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 5
- Study locations
NCT05361707 is a Phase 3 study of Autism Spectrum Disorder and Sleep Disturbance that is actively recruiting participants, run by Vanda Pharmaceuticals. The registered enrollment target is 100 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (26% lower). The trial reports 5 study locations across 3 states.
The verdict
NCT05361707, a Phase 3 study of Autism Spectrum Disorder and Sleep Disturbance, is actively recruiting participants, sponsored by Vanda Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
Conditions Studied
Interventions
- DRUG Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Study Locations (5)
California
- Vanda Investigational Site - San Jose
- Vanda Investigational Site - San Leandro
- Vanda Investigational Site - Santa Monica
Colorado
- Vanda Investigational Site - Boulder
New York
- Vanda Investigational Site - Staten Island
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-07-28 |
| Est. Completion | 2025-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05361707
The ClinicalTrials.gov registry entry for NCT05361707 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (26% lower). The listed sponsor is Vanda Pharmaceuticals, which has 68 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension is the first listed.
NCT05361707 reports 5 study locations spanning 3 distinct geographic areas - top geographies include California, Colorado, New York.
Frequently Asked Questions
What is clinical trial NCT05361707 about?
NCT05361707 is a clinical study titled "Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances". This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
What is the current status of trial NCT05361707?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2021-07-28. Estimated completion is 2025-07.
What conditions does trial NCT05361707 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Sleep Disturbance, Sleep Disorder, Neurological Disorder.
What interventions are being tested in trial NCT05361707?
The interventions under investigation include: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension (DRUG).
Who is sponsoring clinical trial NCT05361707?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05361707 being conducted?
This trial has 5 study locations across California, Colorado, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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