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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001151-16 | EudraCT Number |
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The primary purpose of this study is to assess the long-term safety and tolerability of oral emraclidine in adult participants with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVL-231 30 mg | Experimental | Participants will receive CVL-231 30 milligrams (mg) tablet, once daily for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVL-231 30 mg | Drug | Oral tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 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 Simpson Angus Scale (SAS) Score | Baseline up to Week 52 | |
| Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Abnormal Involuntary Movement Scale (AIMS) Score |
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Inclusion Criteria:
Exclusion Criteria:
Current DSM-5 diagnosis other than schizophrenia (note: anxiety symptoms secondary to schizophrenia are allowed.
Any of the following:
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.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix, Arizona | Phoenix | Arizona | 85012-2707 | United States | ||
| Bryant, Arkansas |
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| 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 |
| Bryant |
| Arkansas |
| 72022-9252 |
| United States |
| Little Rock, Arkansas | Little Rock | Arkansas | 72211-3702 | United States |
| Anaheim, California | Anaheim | California | 92805-5854 | United States |
| Bellflower, California | Bellflower | California | 90706-7079 | United States |
| Culver City, California | Culver City | California | 90230-6632 | United States |
| Garden Grove, California | Garden Grove | California | 92845-2506 | United States |
| La Habra, California | La Habra | California | 90631-3842 | United States |
| Lemon Grove, California | Lemon Grove | California | 91945-2956 | United States |
| Montclair, California | Montclair | California | 91763-2231 | United States |
| Orange,California | Orange | California | 92868-4447 | United States |
| Pico Rivera, California | Pico Rivera | California | 90660-4920 | United States |
| Riverside, California | Riverside | California | 92506-3237 | United States |
| San Diego, California | San Diego | California | 92103-2209 | United States |
| San Diego, California | San Diego | California | 92121 | United States |
| San Diego, California | San Diego | California | 92123 | United States |
| Sherman Oaks, California | Sherman Oaks | California | 91403-1747 | United States |
| Torrance, California | Torrance | California | 90502-4432 | United States |
| Walnut Creek, California | Walnut Creek | California | 94549 | United States |
| New Haven, Connecticut | New Haven | Connecticut | 06519-1109 | United States |
| Bonita Springs,Florida | Bonita Springs | Florida | 34134-4154 | United States |
| Fort Myers, Florida | Fort Myers | Florida | 33901-3711 | United States |
| Hialeah, Florida | Hialeah | Florida | 33012-4648 | United States |
| Hialeah, Florida | Hialeah | Florida | 33016-1814 | United States |
| Miami, Florida | Miami | Florida | 33122-1335 | United States |
| Miami, Florida | Miami | Florida | 33125-5114 | United States |
| Miami, Florida | Miami | Florida | 33155 | United States |
| Miami Lakes, Florida | Miami Lakes | Florida | 33016-1553 | United States |
| Miami Lakes, Florida | Miami Lakes | Florida | 33016 | United States |
| Miami Springs, Florida | Miami Springs | Florida | 33166-7225 | United States |
| Oakland Park, Florida | Oakland Park | Florida | 33334-4135 | United States |
| West Palm Beach, Florida | West Palm Beach | Florida | 33407-2015 | United States |
| Atlanta, Georgia | Atlanta | Georgia | 30318-3102 | United States |
| Atlanta, Georgia | Atlanta | Georgia | 30328-4018 | United States |
| Atlanta, Georgia | Atlanta | Georgia | 30331 | United States |
| Decatur, Georgia | Decatur | Georgia | 30030-3438 | United States |
| Savannah,Georgia | Savannah | Georgia | 31405-5702 | United States |
| Berwyn, Illinois | Berwyn | Illinois | 60402-2248 | United States |
| Chicago, Illinois | Chicago | Illinois | 60611-3478 | United States |
| Chicago, Illinois | Chicago | Illinois | 60622-1702 | United States |
| Chicago, Illinois | Chicago | Illinois | 60623 | United States |
| Chicago, Illinois | Chicago | Illinois | 60640-5017 | United States |
| Chicago, Illinois | Chicago | Illinois | 60641-4023 | United States |
| Marrero, Louisiana | Marrero | Louisiana | 70072-3083 | United States |
| Shreveport, Louisiana | Shreveport | Louisiana | 71101-4603 | United States |
| Gaithersburg, Maryland | Gaithersburg | Maryland | 20877-1409 | United States |
| Flowood, Mississippi | Flowood | Mississippi | 39232-8016 | United States |
| Las Vegas, Nevada | Las Vegas | Nevada | 89102-1972 | United States |
| Berlin, New Jersey | Berlin | New Jersey | 08009 | United States |
| Cedarhurst, New York | Cedarhurst | New York | 11516-1905 | United States |
| New York, New York | New York | New York | 10036-4811 | United States |
| Staten Island, New York | Staten Island | New York | 10314-1607 | United States |
| Charlotte, North Carolina | Charlotte | North Carolina | 28211-4849 | United States |
| North Canton, Ohio | North Canton | Ohio | 44718-2567 | United States |
| Oklahoma City, Oklahoma | Oklahoma City | Oklahoma | 73102-1018 | United States |
| Franklin,Tennessee | Franklin | Tennessee | 37067-5967 | United States |
| Austin, Texas | Austin | Texas | 78754-5122 | United States |
| DeSoto, Texas | DeSoto | Texas | 75115-2066 | United States |
| Houston, Texas | Houston | Texas | 77043 | United States |
| Houston, Texas | Houston | Texas | 77074 | United States |
| Plano, Texas | Plano | Texas | 75093-0010 | United States |
| Richardson, Texas | Richardson | Texas | 75080-3764 | United States |
| Sofia, Sofia-Grad | Sofia | Sofia-Grad | 1202 | Bulgaria |
| Sofia, Sofia-Grad | Sofia | Sofia-Grad | 1407 | Bulgaria |
| Sofia, Sofia-Grad | Sofia | Sofia-Grad | 1431 | Bulgaria |
| Sofia, Sofia-Grad | Sofia | Sofia-Grad | 1510 | Bulgaria |
| Sofia, Sofia-Grad | Sofia | Sofia-Grad | 1606 | Bulgaria |
| Sofia, Sofia-Grad | Sofia | Sofia-Grad | 1680 | Bulgaria |
| Pazardzhik, Pazardzhik | Pazardzhik | 4400 | Bulgaria |
| Pleven, Pleven | Pleven | 5800 | Bulgaria |
| Sliven, Sliven | Sliven | 8800 | Bulgaria |
| Stara Zagora, Stara Zagora | Stara Zagora | 6003 | Bulgaria |
| Varna, Varna | Varna | 9000 | Bulgaria |
| Veliko Tarnovo, Veliko Tarnovo | Veliko Tarnovo | 5000 | Bulgaria |
| Vratsa, Vratsa | Vratsa | 3000 | Bulgaria |
| Kalocsa, Bács-Kiskun | Kalocsa | Bács-Kiskun county | 6300 | Hungary |
| Gyor, Gyor-Moson-Sopron | Győr | Győr-Moson-Sopron | 9024 | Hungary |
| San Juan, Puerto Rico | San Juan | 918 | Puerto Rico |
| San Juan, Puerto Rico | San Juan | 926 | Puerto Rico |
| Ivano Frankivsk, Ivano Frankivsk | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76011 | Ukraine |
| Lviv, L'vivs'ka Oblast | Lviv | Lviv Oblast | 79021 | Ukraine |
| Kropyvnytskyi, Kropyvnytskyi | Kropyvnytskyi | 25491 | Ukraine |
| Kyiv, Kyïv | Kyiv | 04080 | Ukraine |
| Smila, Smila | Smila | 20708 | Ukraine |
| Vinnytsia, Vinnytsia | Vinnytsia | 21018 | Ukraine |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 3, 2026 | Jun 25, 2026 | 28 | ||
| Jul 8, 2026 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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