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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000144-14 | EudraCT Number |
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An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected.
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Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivaracetam 50 mg | Experimental | 50 mg/day |
|
| Brivaracetam 100 mg | Experimental | 100 mg/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivaracetam | Drug | 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase | The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722. | From Week 1 up to Week 17 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study | Baseline through Re-conversion (approximately 31 weeks) | |
| The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29486396 | Result | Arnold S, Badalamenti V, Diaz A, Gasalla T, McShea C, Whitesides J, Fakhoury T. Conversion to brivaracetam monotherapy for the treatment of patients with focal seizures: Two double-blind, randomized, multicenter, historical control, Phase III studies. Epilepsy Res. 2018 Mar;141:73-82. doi: 10.1016/j.eplepsyres.2018.02.005. Epub 2018 Feb 12. |
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The Participant Flow refers to the Randomized Set (RS). Subjects withdrawn due to meeting an exit criterion are included in the count of early discontinuations with a reason of "Adverse Event" or "Lack of efficacy" as reported by the Investigator.
This study started to enroll patients in August 2008 and concluded in February 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brivaracetam 50 mg/Day | Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study) |
| FG001 | Brivaracetam 100 mg/Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Brivaracetam | Drug | 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study) |
|
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| Baseline through Re-conversion (approximately 31 weeks) |
| The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study | Baseline through Re-conversion (approximately 31 weeks) |
| Fresno |
| California |
| United States |
| Pasadena | California | United States |
| Denver | Colorado | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Conyers | Georgia | United States |
| Macon | Georgia | United States |
| Peoria | Illinois | United States |
| Lexington | Kentucky | United States |
| Burlington | Massachusetts | United States |
| Las Vegas | Nevada | United States |
| Summit | New Jersey | United States |
| Mineola | New York | United States |
| New York | New York | United States |
| The Bronx | New York | United States |
| Hickory | North Carolina | United States |
| Kettering | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Germantown | Tennessee | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Danville | Virginia | United States |
| Charleston | West Virginia | United States |
| Waukesha | Wisconsin | United States |
| Chatswood | New South Wales | Australia |
| Adelaide | South Australia | Australia |
| Clayton | Victoria | Australia |
| Fitzroy | Victoria | Australia |
| Parkville | Victoria | Australia |
| West Heidelberg | Victoria | Australia |
| Ghent | Belgium |
| Kortrijk | Belgium |
| Calgary | Alberta | Canada |
| Edmonton | Alberta | Canada |
| Toronto | Ontario | Canada |
| Windsor | Ontario | Canada |
| Sakaskatoon | Saskatchewan | Canada |
| Brno | Czechia |
| Litomyšl | Czechia |
| Ostava | Czechia |
| Ostrava-Trebovice | Czechia |
| Prague | Czechia |
| Praha-4 | Czechia |
| Aschaffenburg | Germany |
| Halle | Germany |
| Mainz | Germany |
| Regensburg | Germany |
| Gothenburg | Sweden |
| Lund | Sweden |
| Stockholm | Sweden |
| Uppsala | Sweden |
Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
| COMPLETED |
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| NOT COMPLETED |
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Demographics refer to the Randomized Set (RS).
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| ID | Title | Description |
|---|---|---|
| BG000 | Brivaracetam 50 mg/Day | Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study) |
| BG001 | Brivaracetam 100 mg/Day | Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study) |
| 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, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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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 | The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase | The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722. | The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs. | Posted | Number | 95% Confidence Interval | proportion of subjects | From Week 1 up to Week 17 |
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| Secondary | The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study | The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication. | Posted | Number | Participants | Baseline through Re-conversion (approximately 31 weeks) |
|
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| Secondary | The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study | The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication. | Posted | Number | Participants | Baseline through Re-conversion (approximately 31 weeks) |
|
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| Secondary | The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study | The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication. | Posted | Number | Participants | Baseline through Re-conversion (approximately 31 weeks) |
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Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one 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 50 mg/Day | Brivaracetam: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study) | 5 | 68 | 33 | 68 | ||
| EG001 | Brivaracetam 100 mg/Day | Brivaracetam: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study) | 0 | 20 | 10 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA13.0 | Non-systematic Assessment |
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| Grand mal convulsion | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
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| Status epilepticus | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA13.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA13.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA13.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA13.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA13.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA13.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA13.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA13.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA13.0 | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA13.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Cares | UCB | +1 877 822 9493 |
| 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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