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

Axial Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Autism Spectrum Disorder (ASD)

Treatments: Drug: AB-2004; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04895215

AXL-2004-002

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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156 participants in 2 patient groups, including a placebo group

AB-2004

Experimental group

Treatment:

Drug: AB-2004

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo