CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 391 enrolled
Drug / intervention
Emraclidine 15 mg +2 moredrug
Likely dose
Emraclidine 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05227703
NCT05227703Phase 2Completed

A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses (15 mg and 30 mg QD) of CVL-231 (Emraclidine) in Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis

AbbVie·interventional·Posted Feb 7, 2022·Updated Oct 28, 2025

In Brief

A Phase 2 clinical trial evaluating Emraclidine 15 mg, Emraclidine 30 mg, and 1 other intervention for Schizophrenia. Completed, enrolled 391 participants across 26 sites in 3 countries.

Detailed Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 6-week trial to evaluate the efficacy, safety, and tolerability of 2 fixed doses of CVL-231 (Emraclidine) (15 mg QD and 30 mg QD) in male and female adult participants who have schizophrenia and are experiencing an acute exacerbation of psychosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesBulgaria, Hungary, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedFeb 7, 2022
Enrollment StartJul 5, 2022
Primary CompletionAug 15, 2024
Study CompletionSep 11, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.4 years ago

Interventions

Emraclidine 15 mgdrug

Emraclidine 15 mg, oral (tablet), once per day (QD) for 6 weeks

Emraclidine 30 mgdrug

Emraclidine 30 mg, oral (tablet), QD for 6 weeks

Placebodrug

Matching placebo, oral (tablet), QD for 6 weeks