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A Study to Evaluate Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Evaluate Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia

A 52-week, Phase 2, Open-label Trial to Evaluate the Long-term Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia

NCT05443724•AbbVie

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to assess the long-term safety and tolerability of oral emraclidine in adult participants with schizophrenia.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Completed 6 weeks of post-randomization treatment in Trial CVL-231-2001 (NCT05227690) or CVL-231-2002 (NCT05227703) and who, in the opinion of the investigator, could potentially benefit from treatment with emraclidine for schizophrenia.
•2. Primary diagnosis of schizophrenia per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), as confirmed by the Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders.
•3. Participants who have been stable on antipsychotic medication for at least one 3-month in the year prior to screening.
•4. Outpatient status at the time of signing the informed consent form informed consent form (ICF).
•5. Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
•6. Ability, in the investigator's opinion, to understand the nature of the trial, participate in trial visits, and comply with protocol requirements.

Exclusion Criteria

•1. Current DSM-5 diagnosis other than schizophrenia (note: anxiety symptoms secondary to schizophrenia are allowed.
•* Acute depressive symptoms within 30 days prior to signing the ICF that require treatment with an antidepressant are exclusory.
•* Acute manic symptoms within 30 days prior to signing the ICF that require treatment with a mood stabilizer are exclusory.
•2. Any of the following:
•* Schizophrenia is considered resistant/refractory to antipsychotic treatment by history (failure to respond to 2 or more courses of adequate pharmacological treatment defined as an adequate dose per label and a treatment duration of at least 4 weeks).
•* History of response to clozapine treatment only or failure to respond to clozapine treatment.
•3. Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
•4. Active central nervous system infection, demyelinating disease, degenerative neurological disease, brain tumor, prior hospitalization for severe head trauma, seizures (excluding febrile seizures in childhood), or any central nervous system disease deemed to be progressive during the trial that may confound the interpretation of the trial results
•5. Diagnosis of moderate to severe substance or alcohol use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the ICF.
•6. Risk for suicidal behavior as assessed by the C-SSRS and investigator's clinical assessment.
+5 more criteria

Locations (85)

Phoenix, Arizona

Phoenix, Arizona, United States

Bryant, Arkansas

Bryant, Arkansas, United States

Little Rock, Arkansas

Little Rock, Arkansas, United States

Anaheim, California

Anaheim, California, United States

Bellflower, California

Bellflower, California, United States

Culver City, California

Culver City, California, United States

Garden Grove, California

Garden Grove, California, United States

La Habra, California

La Habra, California, United States

Lemon Grove, California

Lemon Grove, California, United States

Montclair, California

Montclair, California, United States

Key Dates

Start Date

September 2, 2022

Primary Completion Date

June 25, 2025

Completion Date

June 25, 2025

Last Updated

July 28, 2025

Enrollment

700

ACTUAL participants

Conditions

Schizophrenia

Interventions

CVL-231 30 mg

DRUG

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Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

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Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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