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

March 19, 2024 updated by: Vanda Pharmaceuticals

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95124
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: 202-734-3400
      • San Leandro, California, United States, 94578
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: 202-734-3400
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: 202-734-3400
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: 202-734-3400
    • New York
      • Staten Island, New York, United States, 10312
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: 202-734-3400

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.

Eligibility Criteria

Ages Eligible for Study

2 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion 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.

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 cause sedation or stimulation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tasimelteon
Drug: Tasimelteon
Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Once Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in sleep time over the treatment period, as measured by sleep diary.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires.
Time Frame: 12 weeks
12 weeks
Improvement in objective behavioral parameters such as the participant's overall behavior, as measured by sleep diary in the Patient Global Impression of Severity Behavior Questionnaire (PGI-S Behavior).
Time Frame: 12 weeks
12 weeks
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

July 28, 2021

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

April 29, 2022

First Posted (Actual)

May 5, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VEC-162-3601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Disorder

Clinical Trials on Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe