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

Primary Purpose

Autism Spectrum Disorder (ASD)

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AB-2004
Placebo
Sponsored by
Axial Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder (ASD) focused on measuring Irritability, Anxiety

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Harmonex Neuroscience Research
  • Southwestern Autism Research and Resource Center
  • University of Arizona
  • Cortica Marin
  • Cortica Westlake
  • IMMUNOe Research Centers
  • Yale University
  • CNS Solutions
  • CNS Solutions
  • University of South Florida
  • Baber Research
  • University of Missouri, Thompson Center for Autism and Neurodevelopmental Disorders
  • Clinical Research of Southern Nevada
  • Spectrum Neuroscience and Treatment Institute
  • Nathan S. Kline Institute for Psychiatric Research
  • Ohio State University
  • Vanderbilt University Medical Center
  • Relaro Medical Trials
  • Brain Mind Centre
  • Westmead Children's Hospital
  • Children's Health Queensland Hospital
  • Monash Kids Research
  • Murdoch Children's Research Institute
  • Optimal Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AB-2004

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The mean change in the ABC-I score (Irritability) from Baseline to Week 8 for AB-2004

Secondary Outcome Measures

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
Number of participants who reported treatment emergent adverse events (TEAEs)

Full Information

First Posted
May 17, 2021
Last Updated
September 27, 2023
Sponsor
Axial Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04895215
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axial Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder (ASD)
Keywords
Irritability, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double Blind, Randomized, Placebo Controlled
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AB-2004
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AB-2004
Intervention Description
Taken 3 times daily with food
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Take 3 times daily with food
Primary Outcome Measure Information:
Title
The mean change in the ABC-I score (Irritability) from Baseline to Week 8 for AB-2004
Time Frame
From baseline to Week 8 visit
Secondary Outcome Measure Information:
Title
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
Time Frame
From baseline to Week 8 visit
Title
Number of participants who reported treatment emergent adverse events (TEAEs)
Time Frame
From baseline to Week 8 visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Harmonex Neuroscience Research
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Southwestern Autism Research and Resource Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Cortica Marin
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Cortica Westlake
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
IMMUNOe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
CNS Solutions
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
CNS Solutions
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Baber Research
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
University of Missouri, Thompson Center for Autism and Neurodevelopmental Disorders
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Clinical Research of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Spectrum Neuroscience and Treatment Institute
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Nathan S. Kline Institute for Psychiatric Research
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Relaro Medical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Brain Mind Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Westmead Children's Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Children's Health Queensland Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Monash Kids Research
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3186
Country
Australia
Facility Name
Murdoch Children's Research Institute
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Optimal Clinical Trials
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1010
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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