RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-07-28
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05361707

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.

Ages Eligible for Study:2 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
  2. * A confirmed clinical diagnosis of Autism Spectrum Disorder (ASD) and a recent history of sleep disturbances.
  3. * The sleep disturbance must not be a result of another diagnosable disorder or medication.
  4. * Male or female between 2 and 65 years of age, inclusive.
  5. * Willing and able to comply with study requirements and restrictions.
  1. * Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
  2. * Indication of impaired liver function.
  3. * Evidence of increased risk of self-harm.
  4. * Pregnant or lactating females.
  5. * A positive test for drugs of abuse.
  6. * Other diagnosable causes of sleep disorders or use of medications that may cause sedation or stimulation.

Contacts and Locations

Study Contact

Vanda Pharmaceuticals Inc.
CONTACT
202-734-3400
VEC162@vandapharma.com

Study Locations (Sites)

Vanda Investigational Site
San Jose, California, 95124
United States
Vanda Investigational Site
San Leandro, California, 94578
United States
Vanda Investigational Site
Santa Monica, California, 90404
United States
Vanda Investigational Site
Boulder, Colorado, 80301
United States
Vanda Investigational Site
Staten Island, New York, 10312
United States

Collaborators and Investigators

Sponsor: Vanda Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-28
Study Completion Date2025-07

Study Record Updates

Study Start Date2021-07-28
Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Sleep Disorder
  • Neurological Disorder
  • Sleep Disturbance