Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
NCT ID: NCT05361707
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2021-07-28
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tasimelteon
Drug: Tasimelteon
Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Once Daily
Interventions
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Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Once Daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Years
65 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Vanda Investigational Site
San Jose, California, United States
Vanda Investigational Site
San Leandro, California, United States
Vanda Investigational Site
Santa Monica, California, United States
Vanda Investigational Site
Boulder, Colorado, United States
Vanda Investigational Site
Staten Island, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Other Identifiers
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VP-VEC-162-3601
Identifier Type: -
Identifier Source: org_study_id
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