A Phase 2 interventional study of AB-2004 and Placebo in Autism Spectrum Disorder (ASD), sponsored by Vertero Therapeutics. Completed at 24 sites in 3 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Vertero Therapeutics · Phase 2, Interventional, and Treatment
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.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 156 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Vertero Therapeutics is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: AB-2004
Drug: Placebo
Taken 3 times daily with food
Take 3 times daily with food
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
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
Number of participants who reported treatment emergent adverse events (TEAEs)
Time frame: From baseline to Week 8 visit
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.