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| ID | Type | Description | Link |
|---|---|---|---|
| RPCE07F1216 | |||
| 2008-000145-58 | 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 BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivaracetam (BRV) 1 | Experimental | 50 mg daily |
|
| Brivaracetam (BRV) 2 | Experimental | 100 mg daily |
|
| 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 Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks) |
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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 |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 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 multi-Center study started to enroll subjects in August 2008 and concluded in March 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brivaracetam (BRV) 50 mg | 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 (BRV) 100 mg |
| 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) |
|
|
| Garden Grove |
| California |
| United States |
| Loma Linda | California | United States |
| Newport Beach | California | United States |
| Riverside | California | United States |
| Sacramento | California | United States |
| Stanford | California | United States |
| Denver | Colorado | United States |
| Fort Collins | Colorado | United States |
| Danbury | Connecticut | United States |
| New Haven | Connecticut | United States |
| Waterbury | Connecticut | United States |
| Gainesville | Florida | United States |
| Miami | Florida | United States |
| Atlanta | Georgia | United States |
| Honolulu | Hawaii | United States |
| Chicago | Illinois | United States |
| Danville | Indiana | United States |
| Elkhart | Indiana | United States |
| Waldorf | Maryland | United States |
| Grand Rapids | Michigan | United States |
| Columbia | Missouri | United States |
| Lebanon | New Hampshire | United States |
| Albuquerque | New Mexico | United States |
| Flushing | New York | United States |
| Schenectady | New York | United States |
| Charlotte | North Carolina | United States |
| Oberlin | Ohio | United States |
| Westerville | Ohio | United States |
| Tulsa | Oklahoma | United States |
| Bethlehem | Pennsylvania | United States |
| Jenkintown | Pennsylvania | United States |
| Providence | Rhode Island | United States |
| Austin | Texas | United States |
| Bedford | Texas | United States |
| San Antonio | Texas | United States |
| Layton | Utah | United States |
| Ogden | Utah | United States |
| Burlington | Vermont | United States |
| Bluefield | Virginia | United States |
| Seattle | Washington | United States |
| Morgantown | West Virginia | United States |
| Marshfield | Wisconsin | United States |
| Béthune | France |
| Lille | France |
| Saint-Brieuc | France |
| Toulouse | France |
| Berlin | Germany |
| Bernau | Germany |
| Bielefeld | Germany |
| München | Germany |
| Münster | Germany |
| Ulm | Germany |
| Budapest | Hungary |
| Debrecen | Hungary |
| Kecskemét | Hungary |
| Szeged | Hungary |
| Bergamo | Italy |
| Florence | Italy |
| Germaneto | Italy |
| Messina | Italy |
| Perugia | Italy |
| Pisa | Italy |
| Torino | Italy |
| Barcelona | Spain |
| Madrid | Spain |
| Murcia | Spain |
| Zaragoza | Spain |
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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Baseline Characteristics refer to the Intent-to-Treat Set (ITT), consisting of all randomized subjects with at least 1 intake of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brivaracetam (BRV) 50 mg | 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 (BRV) 100 mg | 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 |
|
| 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 |
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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) consisted of all randomized subjects with at least 1 intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Phase (during the Evaluation Period) and started with the withdrawal of Baseline AEDs. The Outcome Measure was only pre-specified for the "Brivaracetam (BRV) 50 mg" Arm | Posted | Number | 95% Confidence Interval | percentage of subjects | From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks) |
|
|
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Adverse Events were collected from Week 0 over the 1-week BRV Add-On Period and the 15-week Evaluation Period until the end fo Follow-Up Period (Week 23) or Early Discontinuation Visit.
Adverse Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 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 (BRV) 50 mg | 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). | 3 | 47 | 31 | 47 | ||
| EG001 | Brivaracetam (BRV) 100 mg | 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). | 1 | 15 | 10 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA13.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA13.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA13.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA13.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA13.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA13.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA13.0 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA13.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA13.0 | Non-systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA13.0 | Non-systematic Assessment |
| |
| Electrocardiogram ST segment depression | Investigations | MedDRA13.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA13.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA13.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA13.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB (Study Director) | UCB Clinical Trial Call Center | +1 887 822 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 |
|