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

Phase 3

Recruiting

• Conditions: Autism Spectrum Disorder; Sleep Disorder; Neurological Disorder; Sleep Disturbance
• Interventions: Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension

• Registration Number: NCT05361707
• Lead Sponsor: Vanda Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-28
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tasimelteon	Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension	Drug: Tasimelteon

Primary Outcome Measures

Name	Time	Method
Change in sleep time over the treatment period, as measured by sleep diary.	12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Staten Island, New York, United States