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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05361707
• Other study ID #: VP-VEC-162-3601
• Status: Recruiting
• Phase: Phase 3
• Start date: July 28, 2021
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: Vanda Pharmaceuticals
• Contact: Vanda Pharmaceuticals Inc.
• Phone: 202-734-3400
• Email: VEC162[@]vandapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Dyssomnias
• Nervous System Diseases
• Neurological Disorder
• Parasomnias
• Sleep Disorder
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Drug:
• Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Once Daily

Locations

Country	Name	City	State
United States	Vanda Investigational Site	Boulder	Colorado
United States	Vanda Investigational Site	San Jose	California
United States	Vanda Investigational Site	San Leandro	California
United States	Vanda Investigational Site	Santa Monica	California
United States	Vanda Investigational Site	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sleep time over the treatment period, as measured by sleep diary.		12 weeks
Secondary	Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires.		12 weeks
Secondary	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).		12 weeks
Secondary	Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).		12 weeks