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

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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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Tasimelteon
Experimental group
Description:
Drug: Tasimelteon
Treatment:
Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension

Trial contacts and locations

5

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Central trial contact

Vanda Pharmaceuticals Inc.

Data sourced from clinicaltrials.gov

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