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Not listed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05361707

Public ClinicalTrials.gov record NCT05361707. 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.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 8:02 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Study to Evaluate the Efficacy and Safety of Tasimelteon in Treating Sleep Disturbances in Individuals With Autism Spectrum Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05361707
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Vanda Pharmaceuticals
Industry
Enrollment
100 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Years to 65 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
Jul 27, 2021
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025
Last update posted
Mar 20, 2024

2021 – 2025

United States locations

U.S. sites
5
U.S. states
3
U.S. cities
5
Facility City State ZIP Site status
Vanda Investigational Site San Jose California 95124 Recruiting
Vanda Investigational Site San Leandro California 94578 Recruiting
Vanda Investigational Site Santa Monica California 90404 Recruiting
Vanda Investigational Site Boulder Colorado 80301 Recruiting
Vanda Investigational Site Staten Island New York 10312 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05361707, 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 Mar 20, 2024 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05361707 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →