Summary

Eligibility
for people ages 5-17 (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 participants with irritability associated with autism spectrum disorder.

Official Title

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

Keywords

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

Eligibility

You can join if…

Open to people ages 5-17

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

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)

Locations

  • University of California accepting new patients
    San Francisco California 94143 United States
  • Cortica Marin accepting new patients
    San Rafael California 94903 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Axial Therapeutics, Inc.
ID
NCT04895215
Phase
Phase 2 Autism Research Study
Study Type
Interventional
Participants
Expecting 140 study participants
Last Updated