Trials / Completed
CompletedNCT04895215
AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD)
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of AB-2004 in an Autism Spectrum Disorder Population
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 156 (actual)
- Sponsor
- Vertero Therapeutics · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AB-2004 | Taken 3 times daily with food |
| DRUG | Placebo | Take 3 times daily with food |
Timeline
- Start date
- 2021-08-02
- Primary completion
- 2023-11-15
- Completion
- 2023-12-15
- First posted
- 2021-05-20
- Last updated
- 2025-11-21
Locations
24 sites across 3 countries: United States, Australia, New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04895215. Inclusion in this directory is not an endorsement.