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

March 12, 2024 updated by: Cerevel Therapeutics, LLC

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Pazardzhik, Bulgaria, 4400
        • Recruiting
        • Pazardzhik, Pazardzhik
      • Pleven, Bulgaria, 5800
        • Recruiting
        • Pleven, Pleven
        • Contact:
      • Pleven, Bulgaria, 5800
        • Enrolling by invitation
        • Pleven, Pleven
      • Plovdiv, Bulgaria, 4000
        • Active, not recruiting
        • Plovdiv, Plovdiv
      • Sliven, Bulgaria, 8800
      • Stara Zagora, Bulgaria, 6003
        • Enrolling by invitation
        • Stara Zagora, Stara Zagora
      • Varna, Bulgaria, 9000
      • Veliko Tarnovo, Bulgaria, 5000
        • Recruiting
        • Veliko Tarnovo, Veliko Tarnovo
      • Veliko Tarnovo, Bulgaria, 5047
        • Withdrawn
        • Veliko Tarnovo, Veliko Tarnovo
      • Vratsa, Bulgaria, 3000
        • Enrolling by invitation
        • Vratsa, Vratsa
    • Sofia
      • Novi Iskar, Sofia, Bulgaria, 1282
        • Enrolling by invitation
        • Novi Iskar, Sofia
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1202
        • Recruiting
        • Sofia, Sofia-Grad
        • Contact:
      • Sofia, Sofia-Grad, Bulgaria, 1510
      • Sofia, Sofia-Grad, Bulgaria, 1606
        • Recruiting
        • Sofia, Sofia-Grad
        • Contact:
      • Sofia, Sofia-Grad, Bulgaria, 1680
      • Sofia, Sofia-Grad, Bulgaria, 1407
        • Recruiting
        • Sofia, Sofia-Grad
        • Contact:
      • Sofia, Sofia-Grad, Bulgaria, 1431
        • Recruiting
        • Sofia, Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1137
        • Recruiting
        • Sofia, Sofia-Grad
    • Šumen
      • Tsarev Brod, Šumen, Bulgaria, 9747
        • Active, not recruiting
        • Tsarev Brod village, Šumen
  • Hungary
      • Budapest, Hungary, 1083
        • Enrolling by invitation
        • Budapest, Budapest
    • Bács-Kiskun
      • Kalocsa, Bács-Kiskun, Hungary, 6300
        • Enrolling by invitation
        • Kalocsa, Bács-Kiskun
    • Gyor-Moson-Sopron
      • Gyor, Gyor-Moson-Sopron, Hungary, 9024
        • Enrolling by invitation
        • Győr, Győr-Moson-Sopron
  • Puerto Rico
      • San Juan, Puerto Rico, 918
        • Recruiting
        • San Juan, Puerto Rico
      • San Juan, Puerto Rico, 926
        • Recruiting
        • San Juan, Puerto Rico
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012-2707
        • Recruiting
        • Phoenix, Arizona
    • Arkansas
      • Bentonville, Arkansas, United States, 72712-3873
        • Terminated
        • Bentonville, Arkansas
      • Bryant, Arkansas, United States, 72022-9252
        • Recruiting
        • Bryant, Arkansas
        • Contact:
      • Little Rock, Arkansas, United States, 72211-3702
        • Enrolling by invitation
        • Little Rock, Arkansas
    • California
      • Anaheim, California, United States, 92805-5854
      • Anaheim, California, United States, 92805-5854
        • Enrolling by invitation
        • Anaheim, California
      • Bellflower, California, United States, 90706-7079
        • Enrolling by invitation
        • Bellflower, California
      • Culver City, California, United States, 90230-6632
      • Garden Grove, California, United States, 92845-2506
        • Enrolling by invitation
        • Garden Grove, California
      • La Habra, California, United States, 90631-3842
        • Enrolling by invitation
        • La Habra, California
      • Lafayette, California, United States, 94549
        • Recruiting
        • Lafayette, California
        • Contact:
      • Lemon Grove, California, United States, 91945-2956
      • Montclair, California, United States, 91763-2231
        • Enrolling by invitation
        • Montclair, California
      • Orange, California, United States, 92868-4447
        • Recruiting
        • Orange,California
      • Pico Rivera, California, United States, 90660-4920
      • Riverside, California, United States, 92506-3237
        • Enrolling by invitation
        • Riverside, California
      • San Diego, California, United States, 92103-2209
        • Recruiting
        • San Diego, California
      • San Diego, California, United States, 92123
        • Enrolling by invitation
        • San Diego, California
      • Sherman Oaks, California, United States, 91403-1747
        • Enrolling by invitation
        • Sherman Oaks, California
      • Torrance, California, United States, 90502-4432
        • Recruiting
        • Torrance, California
    • Connecticut
      • New Haven, Connecticut, United States, 06519-1109
        • Enrolling by invitation
        • New Haven, Connecticut
    • Florida
      • Clermont, Florida, United States, 34711-5190
        • Active, not recruiting
        • Clermont, Florida
      • Hialeah, Florida, United States, 33016-1814
      • Miami, Florida, United States, 33155
        • Recruiting
        • Miami, Florida
      • Miami, Florida, United States, 33122-1335
        • Enrolling by invitation
        • Miami, Florida
      • Miami, Florida, United States, 33125-5114
        • Recruiting
        • Miami, Florida
      • Miami, Florida, United States, 33155
        • Enrolling by invitation
        • Miami, Florida
      • Miami Lakes, Florida, United States, 33016-1553
        • Recruiting
        • Miami Lakes, Florida
      • Miami Lakes, Florida, United States, 33016-1553
        • Withdrawn
        • Miami Lakes, Florida
      • Miami Springs, Florida, United States, 33166-7225
        • Recruiting
        • Miami Springs, Florida
      • Oakland Park, Florida, United States, 33334-4135
        • Active, not recruiting
        • Oakland Park, Florida
      • West Palm Beach, Florida, United States, 33407-2015
        • Recruiting
        • West Palm Beach, Florida
    • Georgia
      • Atlanta, Georgia, United States, 30328-4018
        • Recruiting
        • Atlanta, Georgia
      • Atlanta, Georgia, United States, 30331
        • Active, not recruiting
        • Atlanta, Georgia
      • Decatur, Georgia, United States, 30030-3438
        • Enrolling by invitation
        • Decatur, Georgia
    • Illinois
      • Chicago, Illinois, United States, 60622-1702
      • Chicago, Illinois, United States, 60611-3478
        • Recruiting
        • Chicago, Illinois
      • Chicago, Illinois, United States, 60641-4023
        • Active, not recruiting
        • Chicago,Illinois
    • Louisiana
      • Marrero, Louisiana, United States, 70072-3083
      • Shreveport, Louisiana, United States, 71101-4603
        • Enrolling by invitation
        • Shreveport, Louisiana
    • Maryland
      • Gaithersburg, Maryland, United States, 20877-1407
        • Enrolling by invitation
        • Gaithersburg, Maryland
    • Mississippi
      • Flowood, Mississippi, United States, 39232-8016
        • Enrolling by invitation
        • Flowood, Mississippi
    • Missouri
      • Saint Louis, Missouri, United States, 63128-3859
        • Active, not recruiting
        • Saint Louis, Missouri
    • Nevada
      • Las Vegas, Nevada, United States, 89102-1972
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Enrolling by invitation
        • Berlin, New Jersey
      • Marlton, New Jersey, United States, 08053
        • Enrolling by invitation
        • Marlton, New Jersey
    • New York
      • Cedarhurst, New York, United States, 11516-1905
      • New York, New York, United States, 10036-4811
        • Recruiting
        • New York, New York
      • Staten Island, New York, United States, 10314-1607
    • North Carolina
      • Charlotte, North Carolina, United States, 28211-4849
        • Enrolling by invitation
        • Charlotte, North Carolina
    • Ohio
      • North Canton, Ohio, United States, 44720
        • Enrolling by invitation
        • North Canton, Ohio
    • Tennessee
      • Franklin, Tennessee, United States, 37067-5967
        • Recruiting
        • Franklin,Tennessee
    • Texas
      • Austin, Texas, United States, 78754-5122
        • Enrolling by invitation
        • Austin, Texas
      • DeSoto, Texas, United States, 75115-2066
        • Recruiting
        • DeSoto, Texas
      • Houston, Texas, United States, 77074
        • Recruiting
        • Houston, Texas
      • Richardson, Texas, United States, 75080-3764
        • Enrolling by invitation
        • Richardson, Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.
  7. Any condition that could possibly affect drug absorption, including, but not limited to bowel resections, bariatric weight loss surgery, gastric banding, and gastrectomy
  8. Use of prohibited medications prior to randomization within the required wash-out period or likely to require prohibited concomitant therapy during the trial.
  9. Clinically significant abnormal findings on the physical examination, medical history review, ECG, or clinical laboratory results at screening.
  10. Positive pregnancy test result prior to receiving investigational medicinal product (IMP).

Note: female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of the IMP are also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CVL-231 30 mg
Participants will receive CVL-231 30 milligrams (mg) tablet, once daily for 52 weeks.
Drug: CVL-231 30 mg
Oral tablets
Other Names:
  • Emraclidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 56
Up to Week 56
Number of Participants With Clinically Significant Changes in Vital Sign Values
Time Frame: Up to Week 52
Up to Week 52
Number of Participants With Clinically Significant Changes in Body Weight
Time Frame: Up to Week 52
Up to Week 52
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Time Frame: Up to Week 52
Up to Week 52
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Time Frame: Up to Week 52
Up to Week 52
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
Time Frame: Up to Week 52
Up to Week 52
Number of Participants With Clinically Significant Changes in Metabolic Parameter Values
Time Frame: Up to Week 52
Up to Week 52
Number of Participants With Clinically Significant Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time Frame: Up to Week 52
Up to Week 52
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Simpson Angus Scale (SAS) Score
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Abnormal Involuntary Movement Scale (AIMS) Score
Time Frame: Baseline up to Week 52
Baseline up to Week 52
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Barnes Akathisia Rating Scale (BARS) Score
Time Frame: Baseline up to Week 52
Baseline up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cerevel Therapeutics, LLC

Investigators

  • Study Director: Erica Koenig, PhD, Cerevel Therapeutics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2022

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

June 29, 2022

First Posted (Actual)

July 5, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVL-231-2003
  • 2022-001151-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on CVL-231 30 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe