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

Status unconfirmed · Phase 3

Conditions studied: Autism Spectrum Disorder, Sleep Disorder, Neurological Disorder, Sleep Disturbance

In brief

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.

Key facts

Study ID

NCT05361707

Run by

Vanda Pharmaceuticals

People needed

100

Starts

2021-07-28

Expected to finish

2025-07-01

Last updated by the study team

2024-03-21

Who can join

Age: 2 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Vanda Investigational Site — San Jose, California, United States (enrolling)
• Vanda Investigational Site — San Leandro, California, United States (enrolling)
• Vanda Investigational Site — Santa Monica, California, United States (enrolling)
• Vanda Investigational Site — Boulder, Colorado, United States (enrolling)
• Vanda Investigational Site — Staten Island, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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