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

NCT04895215 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-11-21

No results posted yet for this study

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.

Conditions

  • Autism Spectrum Disorder (ASD)

Interventions

DRUG

AB-2004

Taken 3 times daily with food

DRUG

Placebo

Take 3 times daily with food

Sponsors & Collaborators

  • Vertero Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2023-11-15
Completion
2023-12-15
FDA Drug
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04895215 on ClinicalTrials.gov