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

Vanda Pharmaceuticals100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Autism Spectrum Disorder Sleep Disorder Neurological Disorder Sleep Disturbance

Interventions

Tasimelteon Oral Capsule, Tasimelteon Liquid SuspensionDRUG

Once Daily

Eligibility

Sex: ALLMin age: 2 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (5)

Vanda Investigational Site

San Jose, California, United States

RECRUITING

Vanda Investigational Site

San Leandro, California, United States

RECRUITING

Vanda Investigational Site

Santa Monica, California, United States

Outcomes

Primary Outcomes

Change in sleep time over the treatment period, as measured by sleep diary.

Time frame: 12 weeks

Secondary Outcomes

Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires.

Time frame: 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

Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).

Time frame: 12 weeks

Central Contacts

Vanda Pharmaceuticals Inc.

CONTACT

202-734-3400 VEC162@vandapharma.com

Data from ClinicalTrials.gov

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