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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to establish the potential benefits, safety, and tolerability of AB-2004 in adolescent participants, aged 13 to 17, with irritability associated with autism spectrum disorder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axial Therapeutics, Inc.

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 visit

• Clinical Global Impression - Severity (CGI-S) scale score ≥4 at the screening visit

• Presence of gastrointestinal symptoms (diarrhea, constipation, abdominal pain, bloating) at the screening visit

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)

• Failure to respond to atypical antipsychotic drugs at therapeutic doses for 4 weeks or longer