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RECRUITING Phase 3

Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances

NCT05361707 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 100 participants
Start Date 2021-07-28
Est. Completion 2025-07
Phase Phase 3

Sponsor

Vanda Pharmaceuticals

34 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanda Pharmaceuticals, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05361707 reports 5 study locations spanning 3 distinct geographic areas — top geographies include California, Colorado, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05361707?

The interventions under investigation include: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05361707?

This trial is sponsored by Vanda Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial