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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001433-98 | EudraCT Number |
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The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivaracetam | Experimental | Brivaracetam at flexible dosing up to 200mg /day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivaracetam | Drug | Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) | Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment. | During the Evaluation Period (up to 9 years) |
| Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) | Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment. | During the Evaluation Period (up to 9 years) |
| Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) | An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | During the Evaluation Period (up to 9 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years) | BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week. |
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Inclusion Criteria:
Exclusion Criteria:
• Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behaviour, or laboratory values which may have an impact on the safety of the subject, as determined by the investigator.
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | +1 844 599 2273(UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 304 | Phoenix | Arizona | United States | |||
| 281 |
| 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, which consisted of all subjects who took at least 1 dose of study drug.
The study started to enroll patients in November 2008 and concluded in March 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brivaracetam | This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2015 | Feb 16, 2018 |
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|
|
| During the Evaluation Period (up to 9 years) |
| Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years) | BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week. | During the Evaluation Period (up to 9 years) |
| Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years) | BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week. | During the Evaluation Period (up to 9 years) |
| Fresno |
| California |
| United States |
| 288 | Pasadena | California | United States |
| 240 | Riverside | California | United States |
| 245 | Sacramento | California | United States |
| 285 | Peoria | Illinois | United States |
| 224 | Indianapolis | Indiana | United States |
| 266 | Lexington | Kentucky | United States |
| 231 | Waldorf | Maryland | United States |
| 278 | Burlington | Massachusetts | United States |
| 270 | New York | New York | United States |
| 284 | Hickory | North Carolina | United States |
| 241 | Columbus | Ohio | United States |
| 265 | Oklahoma City | Oklahoma | United States |
| 297 | Germantown | Tennessee | United States |
| 260 | Austin | Texas | United States |
| 236 | Bedford | Texas | United States |
| 267 | Dallas | Texas | United States |
| 268 | Houston | Texas | United States |
| 211 | Layton | Utah | United States |
| 235 | Ogden | Utah | United States |
| 218 | Burlington | Vermont | United States |
| 279 | Danville | Virginia | United States |
| 277 | Charleston | West Virginia | United States |
| 213 | Marshfield | Wisconsin | United States |
| 400 | Chatswood | New South Wales | Australia |
| 404 | Adelaide | South Australia | Australia |
| 402 | Fitzroy | Victoria | Australia |
| 401 | Parkville | Victoria | Australia |
| 004 | Ghent | Belgium |
| 003 | Kortrijk | Belgium |
| 205 | Calgary | Alberta | Canada |
| 203 | Edmonton | Alberta | Canada |
| 206 | Toronto | Ontario | Canada |
| 023 | Brno | Czechia |
| 020 | Litomyšl | Czechia |
| 021 | Ostava | Czechia |
| 024 | Ostrava-Trebovice | Czechia |
| 026 | Prague | Czechia |
| 040 | Béthune | France |
| 041 | Toulouse | France |
| 055 | Berlin | Germany |
| 056 | Bernau | Germany |
| 054 | Bielefeld | Germany |
| 063 | Mainz | Germany |
| 051 | München | Germany |
| 065 | Regensburg | Germany |
| 072 | Budapest | Hungary |
| 074 | Budapest | Hungary |
| 084 | Bergamo | Italy |
| 082 | Messina | Italy |
| 085 | Orbassano | Italy |
| 083 | Perugia | Italy |
| 080 | Pisa | Italy |
| 090 | Madrid | Spain |
| 100 | Gothenburg | Sweden |
| 102 | Lund | Sweden |
| 101 | Stockholm | Sweden |
| FDA Safety Alerts and Recalls | View source |
| COMPLETED |
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| NOT COMPLETED |
|
|
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 | This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day. |
| 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 |
| ||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) | Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment. | The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug. | Posted | Number | percentage of participants | During the Evaluation Period (up to 9 years) |
|
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) | Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment. | The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug. | Posted | Number | percentage of participants | During the Evaluation Period (up to 9 years) |
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) | An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug. | Posted | Number | percentage of participants | During the Evaluation Period (up to 9 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years) | BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week. | The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period. | Posted | Number | percentage of participants | During the Evaluation Period (up to 9 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years) | BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week. | The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period. | Posted | Number | percentage of participants | During the Evaluation Period (up to 9 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years) | BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week. | The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period. | Posted | Number | percentage of participants | During the Evaluation Period (up to 9 years) |
|
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Adverse events were collected throughout the study (up to 9 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 | Brivaracetam (SS) | This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day. | 1 | 108 | 26 | 108 | 81 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA15.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA15.0 | Non-systematic Assessment |
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| Sudden unexplained death in epilepsy | General disorders | MedDRA15.0 | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA15.0 | Non-systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA15.0 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA15.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Snake bite | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA15.0 | Non-systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA15.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Grand mal convulsion | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Monoplegia | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Postictal state | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
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| Factitious disorder | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
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| Somnambulism | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Pregnancy of partner | Social circumstances | MedDRA15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA15.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA15.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA15.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Headache | 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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| Migraine | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA15.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA15.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2016 | Feb 16, 2018 | SAP_001.pdf |
| 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 |
Not provided
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| Other/Mixed |
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