A Study to Evaluate Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Drug: CVL-231 30 mg
- Registration Number
- NCT05443724
- Lead Sponsor
- AbbVie
- Brief Summary
The primary purpose of this study is to assess the long-term safety and tolerability of oral emraclidine in adult participants with schizophrenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 850
- 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.
- 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.
- Participants who have been stable on antipsychotic medication for at least one 3-month in the year prior to screening.
- Outpatient status at the time of signing the informed consent form informed consent form (ICF).
- Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
- Ability, in the investigator's opinion, to understand the nature of the trial, participate in trial visits, and comply with protocol requirements.
-
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.
-
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.
-
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.
-
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
-
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.
-
Risk for suicidal behavior as assessed by the C-SSRS and investigator's clinical assessment.
-
Any condition that could possibly affect drug absorption, including, but not limited to bowel resections, bariatric weight loss surgery, gastric banding, and gastrectomy
-
Use of prohibited medications prior to randomization within the required wash-out period or likely to require prohibited concomitant therapy during the trial.
-
Clinically significant abnormal findings on the physical examination, medical history review, ECG, or clinical laboratory results at screening.
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CVL-231 30 mg CVL-231 30 mg Participants will receive CVL-231 30 milligrams (mg) tablet, once daily for 52 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events (TEAEs) Up to Week 56 Number of Participants With Clinically Significant Changes in Vital Sign Values Up to Week 52 Number of Participants With Clinically Significant Changes in Body Weight Up to Week 52 Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results Up to Week 52 Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values Up to Week 52 Number of Participants With Clinically Significant Changes in Clinical Laboratory Values Up to Week 52 Number of Participants With Clinically Significant Changes in Metabolic Parameter Values Up to Week 52 Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Simpson Angus Scale (SAS) Score Baseline up to Week 52 Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Barnes Akathisia Rating Scale (BARS) Score Baseline up to Week 52 Number of Participants With Clinically Significant Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score Up to Week 52 Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Abnormal Involuntary Movement Scale (AIMS) Score Baseline up to Week 52
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (66)
Phoenix, Arizona
🇺🇸Phoenix, Arizona, United States
Little Rock, Arkansas
🇺🇸Little Rock, Arkansas, United States
Culver City, California
🇺🇸Culver City, California, United States
Lemon Grove, California
🇺🇸Lemon Grove, California, United States
Atlanta, Georgia
🇺🇸Atlanta, Georgia, United States
Savannah,Georgia
🇺🇸Savannah, Georgia, United States
Bryant, Arkansas
🇺🇸Bryant, Arkansas, United States
Anaheim, California
🇺🇸Anaheim, California, United States
Bellflower, California
🇺🇸Bellflower, California, United States
Garden Grove, California
🇺🇸Garden Grove, California, United States
Orange,California
🇺🇸Orange, California, United States
Torrance, California
🇺🇸Torrance, California, United States
Bonita Springs,Florida
🇺🇸Bonita Springs, Florida, United States
La Habra, California
🇺🇸La Habra, California, United States
Montclair, California
🇺🇸Montclair, California, United States
Pico Rivera, California
🇺🇸Pico Rivera, California, United States
Riverside, California
🇺🇸Riverside, California, United States
San Diego, California
🇺🇸San Diego, California, United States
Sherman Oaks, California
🇺🇸Sherman Oaks, California, United States
New Haven, Connecticut
🇺🇸New Haven, Connecticut, United States
Hialeah, Florida
🇺🇸Hialeah, Florida, United States
Walnut Creek, California
🇺🇸Walnut Creek, California, United States
Miami, Florida
🇺🇸Miami, Florida, United States
Shreveport, Louisiana
🇺🇸Shreveport, Louisiana, United States
Berlin, New Jersey
🇺🇸Berlin, New Jersey, United States
Fort Myers, Florida
🇺🇸Fort Myers, Florida, United States
Oakland Park, Florida
🇺🇸Oakland Park, Florida, United States
Miami Lakes, Florida
🇺🇸Miami Lakes, Florida, United States
West Palm Beach, Florida
🇺🇸West Palm Beach, Florida, United States
Decatur, Georgia
🇺🇸Decatur, Georgia, United States
Flowood, Mississippi
🇺🇸Flowood, Mississippi, United States
Miami Springs, Florida
🇺🇸Miami Springs, Florida, United States
Gaithersburg, Maryland
🇺🇸Gaithersburg, Maryland, United States
Berwyn, Illinois
🇺🇸Berwyn, Illinois, United States
Las Vegas, Nevada
🇺🇸Las Vegas, Nevada, United States
Chicago, Illinois
🇺🇸Chicago, Illinois, United States
Marrero, Louisiana
🇺🇸Marrero, Louisiana, United States
North Canton, Ohio
🇺🇸North Canton, Ohio, United States
Sofia, Sofia-Grad
🇧🇬Sofia, Sofia-Grad, Bulgaria
Pleven, Pleven
🇧🇬Pleven, Bulgaria
Cedarhurst, New York
🇺🇸Cedarhurst, New York, United States
Charlotte, North Carolina
🇺🇸Charlotte, North Carolina, United States
New York, New York
🇺🇸New York, New York, United States
Staten Island, New York
🇺🇸Staten Island, New York, United States
Oklahoma City, Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Pazardzhik, Pazardzhik
🇧🇬Pazardzhik, Bulgaria
Franklin,Tennessee
🇺🇸Franklin, Tennessee, United States
Austin, Texas
🇺🇸Austin, Texas, United States
DeSoto, Texas
🇺🇸DeSoto, Texas, United States
Houston, Texas
🇺🇸Houston, Texas, United States
Plano, Texas
🇺🇸Plano, Texas, United States
Richardson, Texas
🇺🇸Richardson, Texas, United States
Sliven, Sliven
🇧🇬Sliven, Bulgaria
Stara Zagora, Stara Zagora
🇧🇬Stara Zagora, Bulgaria
Varna, Varna
🇧🇬Varna, Bulgaria
Veliko Tarnovo, Veliko Tarnovo
🇧🇬Veliko Tarnovo, Bulgaria
Vratsa, Vratsa
🇧🇬Vratsa, Bulgaria
Kalocsa, Bács-Kiskun
ðŸ‡ðŸ‡ºKalocsa, Bács-Kiskun, Hungary
Gyor, Gyor-Moson-Sopron
ðŸ‡ðŸ‡ºGyor, Gyor-Moson-Sopron, Hungary
San Juan, Puerto Rico
🇵🇷San Juan, Puerto Rico
Ivano Frankivsk, Ivano Frankivsk
🇺🇦Ivano-Frankivs'k, Ivano Frankivsk, Ukraine
Lviv, L'vivs'ka Oblast
🇺🇦Lviv, L'vivs'ka Oblast, Ukraine
Kropyvnytskyi, Kropyvnytskyi
🇺🇦Kropyvnytskyi, Ukraine
Vinnytsia, Vinnytsia
🇺🇦Vinnytsia, Ukraine
Kyiv, Kyïv
🇺🇦Kyiv, Ukraine
Smila, Smila
🇺🇦Smila, Ukraine