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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003228-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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This study is being conducted to further investigate the safety of prolonged exposure to EVP-6124 in subjects with Schizophrenia receiving a stable dose of an atypical antipsychotic who completed double-blind treatment on studies EVP-6124-015 and EVP-6124-016.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVP-6124 low dose | Experimental | low dose Tablet, Once Daily, Day 1 through Day 182 |
|
| EVP-6124, high dose | Experimental | high dose Tablet, Once Daily, Day 1 through Day 182 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVP-6124 | Drug | Arm 1, 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia | All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood/chemistry/urinalysis) | Baseline through Day 182 or Early Termination |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Clinical Global Impression (CGI) - Severity (CGI-S) to Day 182 | Baseline to Day 182 or Early Termination | |
| Change from Baseline in the Clinical Global Impression (CGI) - Change (CGI-C) to Day 182 | Baseline to Day 182 or Early Termination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
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| Change from Baseline in the EuroQol-5D (EQ-5D-5L) to Day 182 | Baseline to Day 182 or Early Termination |
| Change from Baseline in the Columbia Suicide Severity Rating Scale (C-SSRS) to Day 182 | Baseline to Day 182 or Early Termination |
| Change from Baseline in the Client Socio-Demographic and Service Receipt Inventory-European Version (CSSRI-EU) to Day 182 | Baseline to Day 182 or Early Termination |
| Anaheim |
| California |
| United States |
| Bellflower | California | United States |
| Cerritos | California | United States |
| Chino | California | United States |
| Costa Mesa | California | United States |
| Culver City | California | United States |
| Downey | California | United States |
| Escondido | California | United States |
| Garden Grove | California | United States |
| Glendale | California | United States |
| Los Angeles | California | United States |
| Mesa | California | United States |
| Norwalk | California | United States |
| Oakland | California | United States |
| Oceanside | California | United States |
| Orange | California | United States |
| Riverside | California | United States |
| San Diego | California | United States |
| San Gabriel | California | United States |
| Santa Ana | California | United States |
| Sherman Oaks | California | United States |
| Torrance | California | United States |
| Washington D.C. | District of Columbia | United States |
| Lauderhill | Florida | United States |
| Miami | Florida | United States |
| Miami Springs | Florida | United States |
| North Miami | Florida | United States |
| Oakland Park | Florida | United States |
| Orange City | Florida | United States |
| Orlando | Florida | United States |
| Atlanta | Georgia | United States |
| Marietta | Georgia | United States |
| Smyrna | Georgia | United States |
| Chicago | Illinois | United States |
| Oak Brook | Illinois | United States |
| Oak Park | Illinois | United States |
| Wichita | Kansas | United States |
| Lake Charles | Louisiana | United States |
| Shreveport | Louisiana | United States |
| Boston | Massachusetts | United States |
| Minneapolis | Minnesota | United States |
| Flowood | Mississippi | United States |
| Creve Coeur | Missouri | United States |
| O'Fallon | Missouri | United States |
| Saint Charles | Missouri | United States |
| St Louis | Missouri | United States |
| Lincoln | Nebraska | United States |
| Omaha | Nebraska | United States |
| Nashua | New Hampshire | United States |
| Princeton | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Cedarhurst | New York | United States |
| Jamaica | New York | United States |
| New York | New York | United States |
| Charlotte | North Carolina | United States |
| Cleveland | Ohio | United States |
| Shaker Hts. | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Conshohocken | Pennsylvania | United States |
| Jenkintown | Pennsylvania | United States |
| Norristown | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Phoenixville | Pennsylvania | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| Salt Lake City | Utah | United States |
| Bellevue | Washington | United States |
| Spokane | Washington | United States |
| La Plata | Buenos Aires | Argentina |
| Mendoza | Mendoza Province | Argentina |
| C.a.b.a | Argentina |
| Adelaide | South Australia | Australia |
| Melbourne | Victoria | Australia |
| Mechelen | Belgium |
| Calgary | Alberta | Canada |
| Penticton | British Columbia | Canada |
| Chatham | Ontario | Canada |
| Kingston | Ontario | Canada |
| Montreal | Quebec | Canada |
| Medellín | Antioquia | Colombia |
| Barranquilla | Atlántico | Colombia |
| Pereira | Risaralda Department | Colombia |
| Bogota D.C. | Colombia |
| Bogota D.C | Colombia |
| Berlin | Germany |
| Düsseldorf | Germany |
| Leipzig | Germany |
| Mittweida | Germany |
| Stralsund | Germany |
| Catania | CT | Italy |
| Milan | Milano | Italy |
| Roma | RM | Italy |
| Guadalajara | Jalisco | Mexico |
| Mexico City | Mexico City | Mexico |
| Monterrey | Nuevo León | Mexico |
| San Luis Potosí City | San Luis Potosí | Mexico |
| Mexico City | Mexico |
| Bełchatów | Poland |
| Campulung Muscel | Argeş | Romania |
| Oradea | Bihor County | Romania |
| Cluj-Napacu | Cluj | Romania |
| Cluj-Napoca | Cluj | Romania |
| Palazu Mare | Constanța County | Romania |
| Târgu Mureş | Mureș County | Romania |
| Bucharest | Sector 4 | Romania |
| Talagi | Arkhangelskaya oblast | Russia |
| Smolensk | Smolensk Oblast | Russia |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Stavropol | Russia |
| Yaroslavl | Russia |
| Singapore | Singapore | Singapore |
| Salamanca | Castille and León | Spain |
| Zamora | Castille and León | Spain |
| Alcorcón | Madrid | Spain |
| Coslada | Madrid | Spain |
| Madrid | Madrid | Spain |
| Vil. Stepanivka | Kherson Oblast | Ukraine |
| Dnipropetrovsk | Ukraine |
| Ivano-Frankivsk | Ukraine |
| Kharkiv | Ukraine |
| Kyiv | Ukraine |
| Lviv | Ukraine |
| Poltara | Ukraine |
| Poltava | Ukraine |
| Vinnytsia | Ukraine |
| London | United Kingdom |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| C573817 | 7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide |
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