Summary

Eligibility
for people ages 13-17 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

A Three-arm, Parallel Group, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of AB-2004 in a 13 to 17 Year-old Autism Spectrum Disorder Population

Keywords

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

Eligibility

You can join if…

Open to people ages 13-17

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California not yet accepting patients
    San Francisco California 94143 United States
  • University of California, Davis-MIND Institute not yet accepting patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Axial Therapeutics, Inc.
ID
NCT04895215
Phase
Phase 2
Study Type
Interventional
Last Updated