Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
A Study to Evaluate the Efficacy and Safety of Tasimelteon in Treating Sleep Disturbances in Individuals With Autism Spectrum Disorder
1 other identifier
interventional
100
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2021
Typical duration for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 28, 2021
CompletedFirst Submitted
Initial submission to the registry
October 5, 2021
CompletedFirst Posted
Study publicly available on registry
May 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedMarch 21, 2024
March 1, 2024
3.9 years
October 5, 2021
March 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in sleep time over the treatment period, as measured by sleep diary.
12 weeks
Secondary Outcomes (3)
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
Study Arms (1)
Tasimelteon
EXPERIMENTALDrug: Tasimelteon
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Vanda Investigational Site
San Jose, California, 95124, United States
Vanda Investigational Site
San Leandro, California, 94578, United States
Vanda Investigational Site
Santa Monica, California, 90404, United States
Vanda Investigational Site
Boulder, Colorado, 80301, United States
Vanda Investigational Site
Staten Island, New York, 10312, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2021
First Posted
May 5, 2022
Study Start
July 28, 2021
Primary Completion
July 1, 2025
Study Completion
July 1, 2025
Last Updated
March 21, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share