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

Vanda Pharmaceuticals

Status and phase

Enrolling

Phase 3

Conditions

Autism Spectrum Disorder

Sleep Disorder

Neurological Disorder

Sleep Disturbance

Treatments

Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension

Study type

Interventional

Funder types

Industry

Identifiers

NCT05361707

VP-VEC-162-3601

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

2 to 65 years old

Volunteers

No Healthy Volunteers

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.