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

Description

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

Autism Spectrum Disorder, Sleep Disorder, Neurological Disorder, Sleep Disturbance

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Autism Spectrum Disorder
Intervention / Treatment

-

Contacts and Locations

San Jose

Vanda Investigational Site, San Jose, California, United States, 95124

San Leandro

Vanda Investigational Site, San Leandro, California, United States, 94578

Santa Monica

Vanda Investigational Site, Santa Monica, California, United States, 90404

Boulder

Vanda Investigational Site, Boulder, Colorado, United States, 80301

Staten Island

Vanda Investigational Site, Staten Island, New York, United States, 10312

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
  • * A confirmed clinical diagnosis of Autism Spectrum Disorder (ASD) and a recent history of sleep disturbances.
  • * The sleep disturbance must not be a result of another diagnosable disorder or medication.
  • * Male or female between 2 and 65 years of age, inclusive.
  • * Willing and able to comply with study requirements and restrictions.
  • * Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
  • * Indication of impaired liver function.
  • * Evidence of increased risk of self-harm.
  • * Pregnant or lactating females.
  • * A positive test for drugs of abuse.
  • * Other diagnosable causes of sleep disorders or use of medications that may cause sedation or stimulation.

Ages Eligible for Study

2 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanda Pharmaceuticals,

Study Record Dates

2025-07