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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000827-42 | EudraCT Number |
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N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life and to explore the direct medical resource use for BRV (for subjects entering N01372 from a study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of 200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.
Flexible dosing up to 200 mg/day, twice daily (10, 25 and 50 mg oral film-coated tablets). The study will continue until either regulatory approval of BRV has been granted by any Health Authority in an indication of adjunctive treatment of Epilepsy, or until the Sponsor decides to close the study, or until the BRV development is stopped by the Sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivaracetam | Experimental | At Entry Visit (EV), subjects will start on the individualized Brivaracetam (BRV) dose that they had reached at the completion of the previous study. Dose adjustments of the Investigational Medicinal Product (IMP) are allowed at any time based on the clinical judgment of the investigator. The BRV dose can be increased or decreased in increments of 50 mg/day based on the individual subject's seizure control and/or tolerability; however, the BRV dose should not exceed 200 mg/day during the study and must always be administered as a symmetrical morning and evening dose. Upon completion or early discontinuation from this study, there will be a Down-Titration Period in steps of 50 mg/day on a weekly basis until 20 mg/day for 1 week is reached, followed by a Post-Treatment Period (between 2 and 4 weeks) during which the subject will not receive study drug. No down-Titration Period will be applicable if subjects are continued on BRV after they complete this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivaracetam | Drug | Flexible dosing, can up and down-titrate as needed. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) During Evaluation Period | TEAEs were defined as AEs that had onset on or after the day of first study medication dose. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study. | From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months) |
| Percentage of Subjects Withdrawn Due to an Adverse Event (AE) During the Evaluation Period | An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects withdrawn due to an AE. | From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months) |
| Occurrence of a Serious Adverse Event (SAE) During the Evaluation Period | SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defects. Results are presented as the percentage of subjects with at least one SAE during this study. | From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Partial-Onset Seizure (POS) Type I Per 28 Days During the Evaluation Period for Subjects With Focal-onset Epilepsy | The POS frequency is standardized to a 28-day duration. Results are presented as the median number of seizures per 28 days. | From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 103 | Little Rock | Arkansas | United States | |||
| 108 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26899665 | Derived | Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6. |
| Label | URL |
|---|---|
| Product Information | View source |
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Participant Flow refers to the Safety Set (SS), which consisted of all subjects who took at least 1 dose of study drug.
This study started to enroll subjects in October 2012 and concluded in August 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brivaracetam Focal Epilepsy | This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Percentage of Change in Partial-Onset-Seizure (POS) Type I Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected | The POS frequency is standardized to a 28-day duration. Results are presented as the median percentage of reduction per 28 days. Negative values indicate improvement from Baseline. | From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months) |
| 50 % Responder Rate in Partial-Onset-Seizure (POS) Type I Frequency From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected | The POS frequency is standardized to a 28-day duration. A responder is defined as a subject with a >=50% reduction in seizure frequency from the Baseline Period of the previous study. Results are presented as the percentage of subjects with 50 % responder rate in POS Type I frequency. | From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months) |
| Lexington |
| Kentucky |
| United States |
| 109 | New York | New York | United States |
| 106 | Akron | Ohio | United States |
| 110 | Dallas | Texas | United States |
| 102 | Salt Lake City | Utah | United States |
| 201 | Paris | France |
| 303 | Bernau | Germany |
| 300 | Kehl-Kork | Germany |
| 502 | Seville | Spain |
| FDA Safety Alerts and Recalls | View source |
| FG001 | Brivaracetam Generalized Epilepsy | This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristics refer to the Safety Set, which consisted of all subjects who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brivaracetam Focal Epilepsy | This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. |
| BG001 | Brivaracetam Generalized Epilepsy | This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. |
| BG002 | Total Title |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | 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 | Incidence of Treatment Emergent Adverse Events (TEAEs) During Evaluation Period | TEAEs were defined as AEs that had onset on or after the day of first study medication dose. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study. | Posted | Number | percentage of subjects | From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months) |
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| Primary | Percentage of Subjects Withdrawn Due to an Adverse Event (AE) During the Evaluation Period | An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects withdrawn due to an AE. | Posted | Number | percentage of subjects | From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months) |
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| Primary | Occurrence of a Serious Adverse Event (SAE) During the Evaluation Period | SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defects. Results are presented as the percentage of subjects with at least one SAE during this study. | The analysis was performed on the Safety Set (SS), which consisted of all subjects who took at least 1 dose of study drug. | Posted | Number | percentage of subjects | From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Frequency of Partial-Onset Seizure (POS) Type I Per 28 Days During the Evaluation Period for Subjects With Focal-onset Epilepsy | The POS frequency is standardized to a 28-day duration. Results are presented as the median number of seizures per 28 days. | The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period. | Posted | Median | Full Range | Seizures per 28 days | From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months) |
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| Secondary | Percentage of Change in Partial-Onset-Seizure (POS) Type I Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected | The POS frequency is standardized to a 28-day duration. Results are presented as the median percentage of reduction per 28 days. Negative values indicate improvement from Baseline. | The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period. | Posted | Median | Full Range | percentage of change | From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months) |
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| Secondary | 50 % Responder Rate in Partial-Onset-Seizure (POS) Type I Frequency From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected | The POS frequency is standardized to a 28-day duration. A responder is defined as a subject with a >=50% reduction in seizure frequency from the Baseline Period of the previous study. Results are presented as the percentage of subjects with 50 % responder rate in POS Type I frequency. | The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period. | Posted | Number | percentage of subjects | From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months) |
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Adverse events collection started at Day 0 and continued up to 30 days after last intake of study medication.
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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 | Brivaracetam Focal Epilepsy (SS) | This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS). | 5 | 19 | 13 | 19 | ||
| EG001 | Brivaracetam Generalized Epilepsy (SS) | This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS). | 2 | 7 | 5 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA15.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA15.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA15.0 | Non-systematic Assessment |
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| Drowning | General disorders | MedDRA15.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA15.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Status epilepticus | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Conversion disorder | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA15.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA15.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA15.0 | Non-systematic Assessment |
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| Hypertensive emergency | Vascular disorders | MedDRA15.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA15.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA15.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA15.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA15.0 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA15.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
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| Upper respiratory tract | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
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| Crystal urine present | Investigations | MedDRA15.0 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA15.0 | Non-systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA15.0 | Non-systematic Assessment |
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| Protein urine present | Investigations | MedDRA15.0 | Non-systematic Assessment |
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| Urinary casts | Investigations | MedDRA15.0 | Non-systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA15.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA15.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844599 | 2273 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C482793 | brivaracetam |
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| >=65 years |
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| Male |
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| Counts |
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| Participants |
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