Status:
COMPLETED
AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD)
Lead Sponsor:
Vertero Therapeutics
Conditions:
Autism Spectrum Disorder (ASD)
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to establish the potential benefits, safety, and tolerability of AB-2004 in participants with irritability associated with autism spectrum disorder.
Eligibility Criteria
Inclusion
- Key
- Clinically diagnosed, documented ASD (Diagnostic and Statistical Manual of Mental Disorders \[DSM-5\] criteria)
- Aberrant Behavior Checklist - Irritability (ABC-I) score ≥18 at the Screening Period
- Clinical Global Impression - Severity (CGI-S) scale score ≥4 at the Screening Period
- Key
Exclusion
- Use of an oral, injected, or inhaled antibiotic within 30 days prior to screening. Prophylactic oral antibiotic use of no more than 1 dose will be permitted
- Current use of an oral controlled or extended-release medication
- Have a comorbid major psychiatric condition (eg, schizophrenia or bipolar disorder) at screening that in the opinion of the Investigator may interfere with the subject's ability to complete study procedures/comply with study requirements
- Current use of antipsychotics (eg, aripiprazole or risperidone)
Key Trial Info
Start Date :
August 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04895215
Start Date
August 2 2021
End Date
December 15 2023
Last Update
November 21 2025
Active Locations (24)
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1
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
2
Southwestern Autism Research and Resource Center
Phoenix, Arizona, United States, 85006
3
University of Arizona
Tucson, Arizona, United States, 85724
4
Cortica Marin
San Rafael, California, United States, 94903