Recruiting

Phase 3

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

Sponsor:

Vanda Pharmaceuticals

Code:

NCT05361707

Conditions

Autism Spectrum Disorder

Sleep Disorder

Neurological Disorder

Sleep Disturbance

Eligibility Criteria

Sex: All

Age: 2 - 65

Healthy Volunteers: Not accepted

Interventions

Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension

Study Details

Brief 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.

Conditions

Autism Spectrum Disorder

Sleep Disorder

Neurological Disorder

Sleep Disturbance

Study ID

NCT05361707

Start date

Jul 28, 2021

Status verified date

Mar, 2024

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 2 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tasimelteon

Drug: Tasimelteon

Interventions

Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension

Once Daily

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Vanda Pharmaceuticals Inc.

202-734-3400 VEC162@vandapharma.com

Locations

Vanda Investigational Site

Recruiting

San Jose, California, United States, 95124

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

San Leandro, California, United States, 94578

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Santa Monica, California, United States, 90404

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Boulder, Colorado, United States, 80301

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Staten Island, New York, United States, 10312

Contacts

Vanda Pharmaceuticals

202-734-3400

More Information

Sponsor

Vanda Pharmaceuticals

Last update posted

Mar 21, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vanda Pharmaceuticals on 2024-03-21.