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Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)
NAP
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxcarbazepine XR | Other | Open Label Study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxcarbazepine XR | Drug | Open Label Study |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Seizure Rate | Measured as change from baseline to end of study | one year |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Janet K Johnson, PhD | Supernus Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxcarbazepine XR | Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Northport |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| Tucson | Arizona | United States |
| Little Rock | Arkansas | United States |
| Riverside | California | United States |
| West Los Angeles | California | United States |
| Aurora | Colorado | United States |
| Jacksonville | Florida | United States |
| Miami | Florida | United States |
| Sarasota | Florida | United States |
| Springfield | Illinois | United States |
| Lexington | Kentucky | United States |
| Bethesda | Maryland | United States |
| Missoula | Montana | United States |
| New York | New York | United States |
| Oklahoma City | Oklahoma | United States |
| Nashville | Tennessee | United States |
| Baytown | Texas | United States |
| Temple | Texas | United States |
| Blagoevgrad | Bulgaria |
| Pleven | Bulgaria |
| Rousse | Bulgaria |
| Sofia | Bulgaria |
| Varna | Bulgaria |
| Calgary | Alberta | Canada |
| Greenfield Park | Quebec | Canada |
| Dubrovnik | Croatia |
| Zagreb | Croatia |
| Col. Las Palmas | Chihuahua | Mexico |
| Col. Guillermina | Durango | Mexico |
| Guadalajara | Jalisco | Mexico |
| Zapopan | Jalisco | Mexico |
| Mexico City | Mexico City | Mexico |
| San Luis Potosà City | San Luis Potosà | Mexico |
| Aguascalientes | Mexico |
| Puebla City | Mexico |
| Giżycko | Poland |
| Katowice | Poland |
| Krakow | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Warsaw | Poland |
| Wilkowice | Poland |
| Bucharest | Romania |
| Campulung Muscel | Romania |
| Cluj-Napoca | Romania |
| Craiova | Romania |
| Kazan' | Russia |
| Kirov | Russia |
| Kursk | Russia |
| Moscow | Russia |
| Nizhny Novgorod | Russia |
| Novosibirsk | Russia |
| Pyatigorsk | Russia |
| Saint Petersburg | Russia |
| Samara | Russia |
| Smolensk | Russia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxcarbazepine XR | Open Label Study Oxcarbazepine XR: Open Label Study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Seizure Rate | Measured as change from baseline to end of study | Posted | Median | Full Range | percentage of change in seizure rate | one year |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxcarbazepine XR | Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily. | 18 | 214 | 124 | 214 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothermia | General disorders | MedDRA | Systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Prostatic Specific Antigen Increased | Investigations | MedDRA (10.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Grand Mal Convulsion | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Suicidal Behaviour | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Diplopia | Eye disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Somnolence | Nervous system disorders |
| |||
| Balance Disorder | Nervous system disorders |
| |||
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet K. Johnson, PhD | Supernus Pharmaceuticals, Inc | 301-838-2623 | jjohnson@supernus.com |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078330 | Oxcarbazepine |
| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Canada |
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| Poland |
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| Romania |
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| Croatia |
|
| Russian Federation |
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| Bulgaria |
|