ACP-204: ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.
Placebo: ACP-204 matching placebo
This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP
* Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first.
* Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1.
All 3 substudies will be analyzed independently of each other.
Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).
| Facility | City | Region | Status |
|---|---|---|---|
| Chandler Clinical Trials | Chandler | Arizona | Recruiting |
| Clinical Endpoint LLC | Scottsdale | Arizona | Recruiting |
| Advanced Research Center, Inc. | Anaheim | California | Withdrawn |
| ATP Clinical Research | Costa Mesa | California | Recruiting |
| Neuro-Pain Medical Center | Fresno | California | Recruiting |
| National Institute of Clinical Research | Garden Grove | California | Terminated |
| Humanity Clinical Research Corp | Aventura | Florida | Recruiting |
| Arrow Clinical Trials | Daytona Beach | Florida | Recruiting |
| First Excellent Research Group | Doral | Florida | Recruiting |
| New Life Medical Research Center Inc. | Hialeah | Florida | Recruiting |
| Reliable Clinical Research LLC. | Hialeah | Florida | Recruiting |
| Homestead Associates in Research Inc. | Miami | Florida | Recruiting |
| Premier Clinical Research Institute, Inc. | Miami | Florida | Recruiting |
| Central Miami Medical Institute | Miami | Florida | Withdrawn |
| Advanced Clinical Research Network, Corp | Miami | Florida | Recruiting |
| Verus Clinical Research | Miami | Florida | Recruiting |
| Future Care Solution, LLC | Miami | Florida | Recruiting |
| MediClear Medical & Research Center, Inc. | Miami | Florida | Recruiting |
| ABBA Medical Group LLC | Miami | Florida | Recruiting |
| Visionary Investigators Network | Miami | Florida | Withdrawn |
| Quantum Clinical Trials | Miami Beach | Florida | Recruiting |
| New Med Research | Miami Gardens | Florida | Recruiting |
| Floridian Neuroscience Institutue | Miami Lakes | Florida | Recruiting |
| Combined Research Orlando Phase I IV | Orlando | Florida | Recruiting |
| Psych Me Medical Research Inc | Tampa | Florida | Withdrawn |
| Neuroscience Research Institute | West Palm Beach | Florida | Recruiting |
| Revive Research Institute, Inc. | Elgin | Illinois | Withdrawn |
| Grace Research, LLC | Shreveport | Louisiana | Recruiting |
| Khan Revive Research Institute | Rochester Hills | Michigan | Withdrawn |
| Tekton Research, LLC | St Louis | Missouri | Recruiting |
| Alivation Research, LLC | Lincoln | Nebraska | Withdrawn |
| Dent Neurologic Institute | Amherst | New York | Withdrawn |
| Finger Lakes Clinical Research | Rochester | New York | Withdrawn |
| SUNY Upstate Medical University | Syracuse | New York | Recruiting |
| Regional Neurological Associates | The Bronx | New York | Withdrawn |
| Insight Clinical Trials LLC | Beachwood | Ohio | Withdrawn |
| Valley Medical Research | Centerville | Ohio | Withdrawn |
| Abington Neurological Associates | Abington | Pennsylvania | Recruiting |
| Horizon Clinical Research Group | Cypress | Texas | Recruiting |
| Prolato Clinical Research Center-Patton | Houston | Texas | Recruiting |
+ 109 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06159673 on ClinicalTrials.gov ↗ ← All trials in the USA