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A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia

NCT05227703 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 391

Last updated 2025-10-28

Study results available
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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.

Conditions

Interventions

DRUG

Emraclidine 15 mg

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

DRUG

Emraclidine 30 mg

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Julie Adams · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2024-08-15
Completion
2024-09-11
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Hungary

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT05227703 on ClinicalTrials.gov