Clinical trial NCT04895215: AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD)
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of AB-2004 in an Autism Spectrum Disorder Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Autism Spectrum Disorder (ASD)
Keywords: Irritability
Anxiety
Lead sponsor: Axial Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 156
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blind, Randomized, Placebo Controlled
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: The mean change in the ABC-I score (Irritability) from Baseline to Week 8 for AB-2004
timeFrame: From baseline to Week 8 visit
Secondary outcomes:
measure: 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
timeFrame: From baseline to Week 8 visit
measure: Number of participants who reported treatment emergent adverse events (TEAEs)
timeFrame: From baseline to Week 8 visit
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Phoenix
country: United States
facility: Southwestern Autism Research and Resource Center
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: San Rafael
country: United States
facility: Cortica Marin
state: California
city: Westlake Village
country: United States
facility: Cortica Westlake
state: California
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: CNS Solutions
state: Florida
city: Orlando
country: United States
facility: CNS Solutions
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Naperville
country: United States
facility: Baber Research
state: Illinois
city: Columbia
country: United States
facility: University of Missouri, Thompson Center for Autism and Neurodevelopmental Disorders
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research of Southern Nevada
state: Nevada
city: New York
country: United States
facility: Spectrum Neuroscience and Treatment Institute
state: New York
city: Orangeburg
country: United States
facility: Nathan S. Kline Institute for Psychiatric Research
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Relaro Medical Trials
state: Texas
city: Sydney
country: Australia
facility: Brain Mind Centre
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Children's Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Children's Health Queensland Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash Kids Research
state: Victoria
city: Parkville
country: Australia
facility: Murdoch Children's Research Institute
state: Victoria
city: Grafton
country: New Zealand
facility: Optimal Clinical Trials
state: Auckland
Study officials:
References: