Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
Primary Purpose
Autism Spectrum Disorder, Sleep Disorder, Neurological Disorder
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
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.
Sites / Locations
- Vanda Investigational SiteRecruiting
- Vanda Investigational SiteRecruiting
- Vanda Investigational SiteRecruiting
- Vanda Investigational SiteRecruiting
- Vanda Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tasimelteon
Arm Description
Drug: Tasimelteon
Outcomes
Primary Outcome Measures
Change in sleep time over the treatment period, as measured by sleep diary.
Secondary Outcome Measures
Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires.
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).
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05361707
Brief Title
Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
Official Title
A Study to Evaluate the Efficacy and Safety of Tasimelteon in Treating Sleep Disturbances in Individuals With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Sleep Disorder, Neurological Disorder, Sleep Disturbance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tasimelteon
Arm Type
Experimental
Arm Description
Drug: Tasimelteon
Intervention Type
Drug
Intervention Name(s)
Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Intervention Description
Once Daily
Primary Outcome Measure Information:
Title
Change in sleep time over the treatment period, as measured by sleep diary.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires.
Time Frame
12 weeks
Title
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).
Time Frame
12 weeks
Title
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Email
VEC162@vandapharma.com
Facility Information:
Facility Name
Vanda Investigational Site
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
Facility Name
Vanda Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals
Phone
202-734-3400
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances
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