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

Autism Spectrum Disorder (ASD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04895215
• Other study ID #: AXL-2004-002
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 2, 2021
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Axial Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autism Spectrum Disorder (ASD)
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Drug:
• AB-2004
Taken 3 times daily with food
• Placebo
Take 3 times daily with food

Locations

Country	Name	City	State
Australia	Monash Kids Research	Clayton	Victoria
Australia	Murdoch Children's Research Institute	Parkville	Victoria
Australia	Children's Health Queensland Hospital	South Brisbane	Queensland
Australia	Brain Mind Centre	Sydney	New South Wales
Australia	Westmead Children's Hospital	Sydney	New South Wales
New Zealand	Optimal Clinical Trials	Grafton	Auckland
United States	IMMUNOe Research Centers	Centennial	Colorado
United States	University of Missouri, Thompson Center for Autism and Neurodevelopmental Disorders	Columbia	Missouri
United States	Ohio State University	Columbus	Ohio
United States	Relaro Medical Trials	Dallas	Texas
United States	Harmonex Neuroscience Research	Dothan	Alabama
United States	CNS Solutions	Jacksonville	Florida
United States	Clinical Research of Southern Nevada	Las Vegas	Nevada
United States	Baber Research	Naperville	Illinois
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Spectrum Neuroscience and Treatment Institute	New York	New York
United States	Nathan S. Kline Institute for Psychiatric Research	Orangeburg	New York
United States	CNS Solutions	Orlando	Florida
United States	Southwestern Autism Research and Resource Center	Phoenix	Arizona
United States	Cortica Marin	San Rafael	California
United States	University of South Florida	Tampa	Florida
United States	University of Arizona	Tucson	Arizona
United States	Cortica Westlake	Westlake Village	California

Sponsors (1)

Lead Sponsor	Collaborator
Axial Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean change in the ABC-I score (Irritability) from Baseline to Week 8 for AB-2004		From baseline to Week 8 visit
Secondary	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		From baseline to Week 8 visit
Secondary	Number of participants who reported treatment emergent adverse events (TEAEs)		From baseline to Week 8 visit