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

Last updated: March 19, 2024
Sponsor: Vanda Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Sleep Disorders

Autism

Asperger's Disorder

Treatment

Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension

Clinical Study ID

NCT05361707
VP-VEC-162-3601
  • Ages 2-65
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability and acceptance to provide written informed consent of the participant or legalguardian (and assent as required).
  • A confirmed clinical diagnosis of Autism Spectrum Disorder (ASD) and a recent historyof sleep disturbances.
  • The sleep disturbance must not be a result of another diagnosable disorder ormedication.
  • Male or female between 2 and 65 years of age, inclusive.
  • Willing and able to comply with study requirements and restrictions.

Exclusion

Exclusion Criteria:

  • 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 causesedation or stimulation.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Phase: 3
Study Start date:
July 28, 2021
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Vanda Investigational Site

    San Jose, California 95124
    United States

    Active - Recruiting

  • Vanda Investigational Site

    San Leandro, California 94578
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Boulder, Colorado 80301
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Staten Island, New York 10312
    United States

    Active - Recruiting

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