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Completed

NCT Number: NCT04895215

AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD)

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.

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Key information

Conditions

Autism Spectrum Disorder (ASD) Anxiety Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brain Mind Centre, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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 Criteria:

  • 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)

Treatment and study plan

AB-2004

Drug

Taken 3 times daily with food

Placebo

Drug

Take 3 times daily with food

Primary outcomes

  1. The mean change in the ABC-I score (Irritability) from Baseline to Week 8 for AB-2004

    Time frame: From baseline to Week 8 visit

Secondary outcomes

  1. The mean change in the Clinical Global Impression-Severity (CGI-S) from Baseline to Week 8 for AB-2004 High Dose and AB-2004 Low Dose

    Time frame: From baseline to Week 8 visit

  2. Number of participants who reported treatment emergent adverse events (TEAEs)

    Time frame: From baseline to Week 8 visit

Sponsors and collaborators

Lead sponsor

Vertero Therapeutics

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of AB-2004 in an Autism Spectrum Disorder Population

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 20, 2021
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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