AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD)
- Conditions
- Autism Spectrum Disorder (ASD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT04895215
- Lead Sponsor
- Axial Therapeutics, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 156
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AB-2004 AB-2004 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method The mean change in the ABC-I score (Irritability) from Baseline to Week 8 for AB-2004 From baseline to Week 8 visit
- Secondary Outcome Measures
Name Time Method Number of participants who reported treatment emergent adverse events (TEAEs) From baseline to Week 8 visit 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
Trial Locations
- Locations (23)
Harmonex Neuroscience Research
🇺🇸Dothan, Alabama, United States
Southwestern Autism Research and Resource Center
🇺🇸Phoenix, Arizona, United States
Cortica Westlake
🇺🇸Westlake Village, California, United States
CNS Solutions
🇺🇸Orlando, Florida, United States
Baber Research
🇺🇸Naperville, Illinois, United States
University of Missouri, Thompson Center for Autism and Neurodevelopmental Disorders
🇺🇸Columbia, Missouri, 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
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Brain Mind Centre
🇦🇺Sydney, New South Wales, Australia
Westmead Children's Hospital
🇦🇺Sydney, New South Wales, Australia
Children's Health Queensland Hospital
🇦🇺South Brisbane, Queensland, Australia
Murdoch Children's Research Institute
🇦🇺Parkville, Victoria, Australia
Optimal Clinical Trials
🇳🇿Grafton, Auckland, New Zealand
Cortica Marin
🇺🇸San Rafael, California, United States
Relaro Medical Trials
🇺🇸Dallas, Texas, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
IMMUNOe Research Centers
🇺🇸Centennial, Colorado, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Clinical Research of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Monash Kids Research
🇦🇺Clayton, Victoria, Australia