NCT04895215CompletedPhase 2
AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD)
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of AB-2004 in an Autism Spectrum Disorder Population
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 156 (actual)
- First submitted
- 17 May 2021
- Start date
- Aug 2021
- Primary completion date
- Nov 2023
- Lead sponsor
- Vertero Therapeutics
- Diseases
- Autism
- NCT number
- NCT04895215
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 156
- From Aug 2021 to the primary completion date, Nov 2023
- 24 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Current use of antipsychotics (eg, aripiprazole or risperidone)
Who the study is looking for
- 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
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Kids Research Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Murdoch Children's Research Institute Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Children's Health Queensland Hospital Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Westmead Children's Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Brain Mind Centre Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Optimal Clinical Trials Coordinator of this site? Confirm its status | Grafton | New Zealand | Unknown status |
| IMMUNOe Research Centers Coordinator of this site? Confirm its status | Centennial | United States | Unknown status |
| University of Missouri, Thompson Center for Autism and Neurodevelopmental Disorders Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Relaro Medical Trials Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Harmonex Neuroscience Research Coordinator of this site? Confirm its status | Dothan | United States | Unknown status |
| CNS Solutions Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Clinical Research of Southern Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Baber Research Coordinator of this site? Confirm its status | Naperville | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Spectrum Neuroscience and Treatment Institute Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Nathan S. Kline Institute for Psychiatric Research Coordinator of this site? Confirm its status | Orangeburg | United States | Unknown status |
| CNS Solutions Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Southwestern Autism Research and Resource Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Cortica- Marin Coordinator of this site? Confirm its status | San Rafael | United States | Unknown status |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| University of Arizona Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Cortica Westlake Coordinator of this site? Confirm its status | Westlake Village | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.