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

Sponsor

Vanda Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05361707

Collaborator

(none)

100

Enrollment

Locations

Arm

23.1

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder Sleep Disorder Neurological Disorder Sleep Disturbance	Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 28, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tasimelteon Drug: Tasimelteon	Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension Once Daily

Arm

Intervention/Treatment

Experimental: Tasimelteon

Drug: Tasimelteon

Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension

Once Daily

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires. [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). [12 weeks]
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs). [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanda Investigational Site	San Jose	California	United States	95124
2	Vanda Investigational Site	San Leandro	California	United States	94578
3	Vanda Investigational Site	Santa Monica	California	United States	90404
4	Vanda Investigational Site	Boulder	Colorado	United States	80301
5	Vanda Investigational Site	Staten Island	New York	United States	10312