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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000899-17 | EudraCT Number |
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To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Keppra XR (Levetiracetam XR) | Experimental | 1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keppra XR (Levetiracetam XR) | Drug | 500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) | An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Duration of the Treatment Period (6 months-2 years) |
| Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) | A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention. | Duration of the Treatment Period (6 months-2 years) |
| Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period | An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Duration of the Treatment Period (6 months-2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months | Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months. | Study entry through 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center, MD | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dothan | Alabama | United States | ||||
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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The study began December 2007 recruiting in the United States, Poland, Mexico, and the Russian Federation. The study completed March 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Keppra XR (Levetiracetam XR) | 1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months |
Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months. |
| Study entry through 12 months |
| Northport |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| Little Rock | Arkansas | United States |
| Bakersfield | California | United States |
| Loxahatchee Groves | Florida | United States |
| Atlanta | Georgia | United States |
| Suwanee | Georgia | United States |
| Witchita | Kansas | United States |
| Detroit | Michigan | United States |
| Camden | New Jersey | United States |
| Buffalo | New York | United States |
| Cedarhurst | New York | United States |
| Toledo | Ohio | United States |
| Tulsa | Oklahoma | United States |
| San Antonio | Texas | United States |
| Aguascalientes | Mexico |
| Guadalajara | Mexico |
| Guadalajara Jalisco | Mexico |
| Mexico City | Mexico |
| Monterrey | Mexico |
| Bialystok | Poland |
| Gdansk | Poland |
| Katowice | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Poznan | Poland |
| Szczecin | Poland |
| Warsaw | Poland |
| Kalingrad | Russia |
| Kazan' | Russia |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Samara | Russia |
| Yaroslavl | Russia |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Keppra XR (Levetiracetam XR) | 1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) | An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here. | Posted | Number | number of subjects | Duration of the Treatment Period (6 months-2 years) |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) | A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention. | Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here. | Posted | Number | number of subjects | Duration of the Treatment Period (6 months-2 years) |
|
| |||||||||||||||||||||||||||
| Primary | Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period | An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Of the 190 subjects beginning the study, 189 received at least one dose of study medication, placing them in the Safety Set (SS) analyzed here. | Posted | Number | number of subjects | Duration of the Treatment Period (6 months-2 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months | Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months. | Of the 190 subjects beginning the study, 139 are in the Efficacy (EFF) population, entered the study on Keppra XR monotherapy, and have been exposed to treatment for at least 6 months. The Efficacy population includes subjects that are in the Safety Set (SS) with at least one reported efficacy measure. | Posted | Number | percentage of subjects | Study entry through 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months | Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months. | Of the 190 subjects beginning the study, 49 are in the Efficacy (EFF) population, entered the study on Keppra XR monotherapy, and have been exposed to treatment for at least 12 months. The Efficacy population includes subjects that are in the Safety Set (SS) with at least one reported efficacy measure. | Posted | Number | percentage of subjects | Study entry through 12 months |
|
|
Up to two years
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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 | Keppra XR (Levetiracetam XR) | 1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years) | 22 | 189 | 57 | 189 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Drowning | General disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Hepatic fibrosis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Anticonvulsant toxicity | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Lumbar puncture headache | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
| |
| Periostitis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Postictal paralysis | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (9.0) | Non-systematic Assessment |
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| Pregnancy with contraceptive device | Pregnancy, puerperium and perinatal conditions | MedDRA (9.0) | Non-systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Anuria | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB (Study Director) | UCB Clinical Trial Call Center | +1 887 822 9493 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Poland |
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| Russian Federation |
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