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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001856-35 | EudraCT Number |
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This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in twice a day administration) as add on therapy in subjects with focal epilepsy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo tablets administered twice a day |
|
| Brivaracetam 50 mg/day | Experimental | Brivaracetam 50 mg/day, 25 mg administered twice a day |
|
| Brivaracetam 150 mg/day | Experimental | Brivaracetam 150 mg/day, 75 mg administered twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Daily oral dose of two equal intakes, morning and evening, of placebo in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period) |
| Measure | Description | Time Frame |
|---|---|---|
| Partial onset seizure frequency (Type I) per week over the 7-week maintenance period | Partial onset seizure frequency (Type I) per week over the 7-week maintenance period | 7-week maintenance period |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period | During the Maintenance period (approximately 7 weeks) | |
| Percentage of reduction from Baseline in seizure frequency per week for partial onset seizures (type I) over the 7-week Maintenance period |
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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 |
|---|---|---|---|---|---|---|
| Bruges | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35285519 | Derived | Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3(3):CD011501. doi: 10.1002/14651858.CD011501.pub3. | |
| 33461041 | Derived | Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4. |
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| Brivaracetam | Drug | Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period) |
|
| Brivaracetam | Drug | Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 150 mg/day in a double-blinded way for the 10-week Treatment Period (3 weeks up-titration followed by 7-week maintenance period) |
|
| During the Maintenance period (approximately 7 weeks) |
| Percentage of reduction from Baseline in seizure frequency per week for all seizures (types I+II+III) over the 7-week Maintenance period | During the Maintenance period (approximately 7 weeks) |
| Responder rate in partial onset seizures (type I) over the 7-week Maintenance period | A responder was defined as a subject with a ≥ 50% reduction in seizure frequency per week from the Baseline period to the Maintenance period. | During the Maintenance period (approximately 7 weeks) |
| Response to treatment in partial onset seizures (type I) over the 7-week Maintenance period | The percentage reduction from Baseline in partial seizure frequency per week over the Maintenance period was grouped in 5 categories: < -25%, -25% to < 25%, 25% to < 75%, 75% to ≤ 100%, and 100%. | During the Maintenance period (approximately 7 weeks) |
| Percentage of seizure-free subjects over the 7-week Maintenance period | During the Maintenance period (approximately 7 weeks) |
| Percentage of seizure-free days per 4 weeks over Baseline and Maintenance periods | Baseline through Maintenance period (approximately 11 weeks) |
| Time to N-th seizure in the Maintenance period | During the Maintenance period (approximately 7 weeks) |
| Brussels |
| Belgium |
| Duffel | Belgium |
| Edegem | Belgium |
| Leuven | Belgium |
| Liège | Belgium |
| Beroun | Czechia |
| Brno | Czechia |
| České Budějovice | Czechia |
| Prague | Czechia |
| Kuopio | Finland |
| Oys (Oulu) | Finland |
| Tampere | Finland |
| Angers | France |
| Béthune | France |
| Dijon | France |
| Grenoble | France |
| Lille | France |
| Lyon | France |
| Marseille | France |
| Montpellier | France |
| Nancy | France |
| Paris | France |
| Rennes | France |
| Strasbourg | France |
| Tain-l'Hermitage | France |
| Toulouse | France |
| Berlin | Germany |
| Bielefeld | Germany |
| Bonn | Germany |
| Chemnitz | Germany |
| Erlangen | Germany |
| Essen | Germany |
| Frankfurt | Germany |
| Freiburg im Breisgau | Germany |
| Kehl | Germany |
| München | Germany |
| Ulm | Germany |
| Heemstede | Netherlands |
| Heeze | Netherlands |
| Gdansk | Poland |
| Katowice | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Szczecin | Poland |
| Warsaw | Poland |
| Madrid | Spain |
| Valencia | Spain |
| Vigo | Spain |
| Bucks | United Kingdom |
| Cambridge | United Kingdom |
| Cardiff | United Kingdom |
| Glasgow | United Kingdom |
| Hartshill | United Kingdom |
| Liverpool | United Kingdom |
| Newcastle | United Kingdom |
| 31937513 | Derived | Brandt C, Klein P, Badalamenti V, Gasalla T, Whitesides J. Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis. Epilepsy Behav. 2020 Feb;103(Pt A):106864. doi: 10.1016/j.yebeh.2019.106864. Epub 2020 Jan 12. |
| 22813235 | Derived | Van Paesschen W, Hirsch E, Johnson M, Falter U, von Rosenstiel P. Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: a phase IIb, randomized, controlled trial. Epilepsia. 2013 Jan;54(1):89-97. doi: 10.1111/j.1528-1167.2012.03598.x. Epub 2012 Jul 19. |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| 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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