Status:
RECRUITING
Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Autism Spectrum Disorder
Sleep Disorder
Eligibility:
All Genders
2-65 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05361707
Start Date
July 28 2021
End Date
July 1 2025
Last Update
March 21 2024
Active Locations (5)
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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