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

Vertero Therapeutics23 sites in 3 countries156 target enrollmentAugust 2, 2021

ConditionsAutism Spectrum Disorder (ASD)

InterventionsAB-2004 Placebo

DrugsAB-2004 Placebo

Overview

Phase: Phase 2
Intervention: AB-2004
Conditions: Autism Spectrum Disorder (ASD)
Sponsor: Vertero Therapeutics
Enrollment: 156
Locations: 23
Primary Endpoint: The mean change in the ABC-I score (Irritability) from Baseline to Week 8 for AB-2004
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2, 2021

End Date

December 15, 2023

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vertero Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

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

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)

Arms & Interventions

AB-2004

Intervention: AB-2004

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

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)