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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443724
• Other study ID #: CVL-231-2003
• Secondary ID: 2022-001151-16
• Status: Recruiting
• Phase: Phase 2
• Start date: September 2, 2022
• Est. completion date: February 2026

Study information

• Verified date: May 2024
• Source: Cerevel Therapeutics, LLC
• Contact: Cerevel Clinical Trial Support
• Email: cerevelclinicaltrials[@]cerevel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• CVL-231 30 mg
Oral tablets

Locations

Country	Name	City	State
Bulgaria	Novi Iskar, Sofia	Novi Iskar	Sofia
Bulgaria	Pazardzhik, Pazardzhik	Pazardzhik
Bulgaria	Pleven, Pleven	Pleven
Bulgaria	Pleven, Pleven	Pleven
Bulgaria	Plovdiv, Plovdiv	Plovdiv
Bulgaria	Sliven, Sliven	Sliven
Bulgaria	Sofia, Sofia-Grad	Sofia	Sofia-Grad
Bulgaria	Sofia, Sofia-Grad	Sofia	Sofia-Grad
Bulgaria	Sofia, Sofia-Grad	Sofia	Sofia-Grad
Bulgaria	Sofia, Sofia-Grad	Sofia	Sofia-Grad
Bulgaria	Sofia, Sofia-Grad	Sofia	Sofia-Grad
Bulgaria	Sofia, Sofia-Grad	Sofia	Sofia-Grad
Bulgaria	Sofia, Sofia-Grad	Sofia	Sofia-Grad
Bulgaria	Stara Zagora, Stara Zagora	Stara Zagora
Bulgaria	Tsarev Brod village, Šumen	Tsarev Brod	Šumen
Bulgaria	Varna, Varna	Varna
Bulgaria	Veliko Tarnovo, Veliko Tarnovo	Veliko Tarnovo
Bulgaria	Veliko Tarnovo, Veliko Tarnovo	Veliko Tarnovo
Bulgaria	Vratsa, Vratsa	Vratsa
Hungary	Budapest, Budapest	Budapest
Hungary	Gyor, Gyor-Moson-Sopron	Gyor	Gyor-Moson-Sopron
Hungary	Kalocsa, Bács-Kiskun	Kalocsa	Bács-Kiskun
Puerto Rico	San Juan, Puerto Rico	San Juan
Puerto Rico	San Juan, Puerto Rico	San Juan
Ukraine	Ivano Frankivsk, Ivano Frankivsk	Ivano-Frankivs'k	Ivano Frankivsk
Ukraine	Kropyvnytskyi, Kropyvnytskyi	Kropyvnytskyi
Ukraine	Kyiv, Kyïv	Kyiv
Ukraine	Smila, Smila	Smila
Ukraine	Vinnytsia, Vinnytsia	Vinnytsia
United States	Anaheim, California	Anaheim	California
United States	Anaheim, California	Anaheim	California
United States	Atlanta, Georgia	Atlanta	Georgia
United States	Atlanta, Georgia	Atlanta	Georgia
United States	Austin, Texas	Austin	Texas
United States	Bellflower, California	Bellflower	California
United States	Bentonville, Arkansas	Bentonville	Arkansas
United States	Berlin, New Jersey	Berlin	New Jersey
United States	Berwyn, Illinois	Berwyn	Illinois
United States	Bryant, Arkansas	Bryant	Arkansas
United States	Cedarhurst, New York	Cedarhurst	New York
United States	Charlotte, North Carolina	Charlotte	North Carolina
United States	Chicago, Illinois	Chicago	Illinois
United States	Chicago, Illinois	Chicago	Illinois
United States	Chicago, Illinois	Chicago	Illinois
United States	Chicago,Illinois	Chicago	Illinois
United States	Clermont, Florida	Clermont	Florida
United States	Culver City, California	Culver City	California
United States	Decatur, Georgia	Decatur	Georgia
United States	DeSoto, Texas	DeSoto	Texas
United States	Flowood, Mississippi	Flowood	Mississippi
United States	Franklin,Tennessee	Franklin	Tennessee
United States	Gaithersburg, Maryland	Gaithersburg	Maryland
United States	Garden Grove, California	Garden Grove	California
United States	Hialeah, Florida	Hialeah	Florida
United States	Houston, Texas	Houston	Texas
United States	La Habra, California	La Habra	California
United States	Lafayette, California	Lafayette	California
United States	Las Vegas, Nevada	Las Vegas	Nevada
United States	Lemon Grove, California	Lemon Grove	California
United States	Little Rock, Arkansas	Little Rock	Arkansas
United States	Marlton, New Jersey	Marlton	New Jersey
United States	Marrero, Louisiana	Marrero	Louisiana
United States	Miami, Florida	Miami	Florida
United States	Miami, Florida	Miami	Florida
United States	Miami, Florida	Miami	Florida
United States	Miami Lakes, Florida	Miami Lakes	Florida
United States	Miami Lakes, Florida	Miami Lakes	Florida
United States	Miami Springs, Florida	Miami Springs	Florida
United States	Montclair, California	Montclair	California
United States	New Haven, Connecticut	New Haven	Connecticut
United States	New York, New York	New York	New York
United States	North Canton, Ohio	North Canton	Ohio
United States	Oakland Park, Florida	Oakland Park	Florida
United States	Orange,California	Orange	California
United States	Phoenix, Arizona	Phoenix	Arizona
United States	Pico Rivera, California	Pico Rivera	California
United States	Plano, Texas	Plano	Texas
United States	Richardson, Texas	Richardson	Texas
United States	Riverside, California	Riverside	California
United States	Saint Louis, Missouri	Saint Louis	Missouri
United States	San Diego, California	San Diego	California
United States	San Diego, California	San Diego	California
United States	Sherman Oaks, California	Sherman Oaks	California
United States	Shreveport, Louisiana	Shreveport	Louisiana
United States	Staten Island, New York	Staten Island	New York
United States	Torrance, California	Torrance	California
United States	West Palm Beach, Florida	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cerevel Therapeutics, LLC

Countries where clinical trial is conducted

United States,  Bulgaria,  Hungary,  Puerto Rico,  Ukraine, 

Outcome

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