Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019361-28 | EudraCT Number |
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This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo tablets administered twice daily |
|
| Brivaracetam 100 mg/ day | Experimental | Brivaracetam 50 mg/ day administered twice daily. |
|
| Brivaracetam 200 mg/ day | Experimental | Brivaracetam 100 mg/ day administered twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Daily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Primary endpoint: United States of America (FDA) | 12 week Treatment Period |
| 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration. | Baseline to 12 week Treatment Period |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period | Baseline to 12 week Treatment Period | |
| Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period |
Not provided
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 |
|---|---|---|---|---|---|---|
| 001 | Phoenix | Arizona | United States | |||
| 013 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27265725 | Result | Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6. | |
| 27335114 | Result |
| Label | URL |
|---|---|
| Product Information | View source |
Not provided
The Participant Flow and Baseline Demographics data is taken from the Randomized Set (RS). The RS consists of all subjects who were randomized.
Recruitment for the N01358 study began in December 2010. The study concluded in May 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo tablets administered twice daily |
| FG001 | Brivaracetam 100 mg/Day | Brivaracetam 50 mg administered twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Brivaracetam | Drug | Daily oral dose of two equal intakes of Brivaracetam 100 mg/ day in a double-blinded way for the 12-week treatment period |
|
| Brivaracetam | Drug | Daily oral dose of two equal intakes of Brivaracetam 200 mg/ day in a double-blinded way for the 12-week treatment period. |
|
| Antiepileptic drugs with market authorization available per country | Drug |
|
| Baseline to 12 week Treatment Period |
| Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period | 12 week Treatment Period |
| All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period | 12 week Treatment Period |
| Time to the First Type I Seizure During the Treatment Period | 12 week Treatment Period |
| Time to the Fifth Type I Seizure During the Treatment Period | 12 week Treatment Period |
| Time to the Tenth Type I Seizure During the Treatment Period | 12 week Treatment Period |
| Phoenix |
| Arizona |
| United States |
| 006 | Tucson | Arizona | United States |
| 775 | Little Rock | Arkansas | United States |
| 045 | Sacramento | California | United States |
| 025 | San Francisco | California | United States |
| 060 | Aurora | Colorado | United States |
| 085 | Colorado Springs | Colorado | United States |
| 071 | Miami | Florida | United States |
| 110 | Miami | Florida | United States |
| 073 | Naples | Florida | United States |
| 090 | Ocala | Florida | United States |
| 027 | Orlando | Florida | United States |
| 064 | Port Charlotte | Florida | United States |
| 044 | Sarasota | Florida | United States |
| 023 | Atlanta | Georgia | United States |
| 063 | Atlanta | Georgia | United States |
| 062 | Columbus | Georgia | United States |
| 048 | Rome | Georgia | United States |
| 039 | Boise | Idaho | United States |
| 005 | Peoria | Illinois | United States |
| 017 | Winfield | Illinois | United States |
| 020 | Ames | Iowa | United States |
| 069 | Iowa City | Iowa | United States |
| 780 | Lexington | Kentucky | United States |
| 092 | Hammond | Louisiana | United States |
| 008 | Bethesda | Maryland | United States |
| 068 | Waldorf | Maryland | United States |
| 055 | East Lansing | Michigan | United States |
| 009 | Golden Valley | Minnesota | United States |
| 051 | Missoula | Montana | United States |
| 032 | Lebanon | New Hampshire | United States |
| 042 | Hamilton | New Jersey | United States |
| 058 | Voorhees Township | New Jersey | United States |
| 095 | Kingston | New York | United States |
| 022 | New York | New York | United States |
| 099 | New York | New York | United States |
| 098 | Poughkeepsie | New York | United States |
| 010 | Asheville | North Carolina | United States |
| 003 | Durham | North Carolina | United States |
| 096 | Canton | Ohio | United States |
| 034 | Cleveland | Ohio | United States |
| 070 | Columbus | Ohio | United States |
| 002 | Toledo | Ohio | United States |
| 043 | Oklahoma City | Oklahoma | United States |
| 091 | Oklahoma City | Oklahoma | United States |
| 054 | Tulsa | Oklahoma | United States |
| 015 | Philadelphia | Pennsylvania | United States |
| 028 | Charleston | South Carolina | United States |
| 021 | Port Royal | South Carolina | United States |
| 050 | Arlington | Texas | United States |
| 061 | Austin | Texas | United States |
| 011 | Dallas | Texas | United States |
| 035 | Dallas | Texas | United States |
| 049 | Houston | Texas | United States |
| 036 | Charlottesville | Virginia | United States |
| 033 | Seattle | Washington | United States |
| 056 | Spokane | Washington | United States |
| 052 | Madison | Wisconsin | United States |
| 057 | Milwaukee | Wisconsin | United States |
| 089 | Casper | Wyoming | United States |
| 202 | Innsbruck | Austria |
| 201 | Linz | Austria |
| 200 | Vienna | Austria |
| 203 | Vienna | Austria |
| 226 | Hechteleksel | Belgium |
| 227 | Leuven | Belgium |
| 228 | Liège | Belgium |
| 104 | Belo Horizonte | Brazil |
| 100 | Florianópolis | Brazil |
| 103 | Riberao Preto | Brazil |
| 101 | São Paulo | Brazil |
| 294 | Blagoevrad | Bulgaria |
| 286 | Sofia | Bulgaria |
| 287 | Sofia | Bulgaria |
| 075 | Calgary | Alberta | Canada |
| 078 | London | Ontario | Canada |
| 076 | Toronto | Ontario | Canada |
| 077 | Greenfield Park | Quebec | Canada |
| 079 | Montreal | Quebec | Canada |
| 080 | Saskatoon | Saskatchewan | Canada |
| 916 | KroměřÞ | Czechia |
| 251 | Ostrava | Czechia |
| 256 | Ostrava | Czechia |
| 913 | Ostrava Poruba | Czechia |
| 252 | Prague | Czechia |
| 253 | Prague | Czechia |
| 250 | ZlÃn | Czechia |
| 650 | Tallinn | Estonia |
| 652 | Tallinn | Estonia |
| 653 | Tallinn | Estonia |
| 651 | Tartu | Estonia |
| 275 | Kuopio | Finland |
| 278 | Oulu | Finland |
| 276 | Tampere | Finland |
| 277 | Turku | Finland |
| 301 | Béthune | France |
| 308 | Marseille | France |
| 305 | Montpellier | France |
| 329 | Berlin | Germany |
| 326 | Bernau | Germany |
| 332 | Bielefeld | Germany |
| 902 | Erlangen | Germany |
| 331 | Göttingen | Germany |
| 904 | Kehl-Kork | Germany |
| 327 | Kiel | Germany |
| 900 | Marburg | Germany |
| 335 | München | Germany |
| 334 | Osnabrück | Germany |
| 330 | Ravensburg | Germany |
| 328 | Ulm | Germany |
| 701 | Hong Kong | Hong Kong |
| 700 | Shatin | Hong Kong |
| 410 | Budapest | Hungary |
| 411 | Budapest | Hungary |
| 412 | Budapest | Hungary |
| 414 | Debrecen | Hungary |
| 413 | Kecskemét | Hungary |
| 727 | Hyderabad | Andhra Pradesh | India |
| 725 | Mumbai | Maharashtra | India |
| 728 | Mumbai | Maharashtra | India |
| 731 | Nashik | Maharashtra | India |
| 726 | Bangalore | India |
| 729 | Madurai | India |
| 377 | Monserrato | Cagliari | Italy |
| 378 | Bari | Italy |
| 380 | Florence | Italy |
| 379 | Milan | Italy |
| 386 | Naples | Italy |
| 376 | Perugia | Italy |
| 375 | Pisa | Italy |
| 383 | Pozzilli | Italy |
| 384 | Reggio Calabria | Italy |
| 382 | Torino | Italy |
| 855 | Hiroshima | Japan |
| 852 | Itami | Japan |
| 850 | Osaka | Japan |
| 851 | Shizuoka | Japan |
| 854 | Yokohama | Japan |
| 627 | Daugapils | Latvia |
| 629 | Jēkabpils | Latvia |
| 626 | Riga | Latvia |
| 628 | Riga | Latvia |
| 625 | Valmiera | Latvia |
| 425 | Alytus | Lithuania |
| 427 | Kaunas | Lithuania |
| 426 | Vilnius | Lithuania |
| 126 | Guadalajara | Jalisco | Mexico |
| 128 | Guadalajara | Jalisco | Mexico |
| 129 | Aguascalientes | Mexico |
| 127 | Culiacán | Mexico |
| 125 | Distrito Federal | Mexico |
| 130 | Mexico City | Mexico |
| 401 | Heemstede | Netherlands |
| 400 | Heeze | Netherlands |
| 403 | Zwolle | Netherlands |
| 475 | Bialystok | Poland |
| 485 | Gdansk | Poland |
| 791 | Gdansk | Poland |
| 478 | Katowice | Poland |
| 480 | Katowice | Poland |
| 481 | Katowice | Poland |
| 476 | Krakow | Poland |
| 793 | Krakow | Poland |
| 483 | Lublin | Poland |
| 477 | Poznan | Poland |
| 479 | Poznan | Poland |
| 482 | Poznan | Poland |
| 488 | Warsaw | Poland |
| 038 | San Juan | Puerto Rico |
| 501 | Kazan' | Russia |
| 506 | Kazan' | Russia |
| 502 | Moscow | Russia |
| 503 | Moscow | Russia |
| 505 | Moscow | Russia |
| 509 | Nizhny Novgorod | Russia |
| 508 | Smolensk | Russia |
| 753 | Busan | South Korea |
| 752 | Gwangju | South Korea |
| 750 | Seoul | South Korea |
| 751 | Seoul | South Korea |
| 754 | Seoul | South Korea |
| 536 | Badalona | Spain |
| 528 | Barcelona | Spain |
| 529 | Barcelona | Spain |
| 535 | Barcelona | Spain |
| 540 | Barcelona | Spain |
| 539 | Donostia / San Sebastian | Spain |
| 532 | Santiago de Compostela | Spain |
| 527 | Valencia | Spain |
| 537 | Valencia | Spain |
| 526 | Valladolid | Spain |
| 551 | Gothenburg | Sweden |
| 552 | Linköping | Sweden |
| 550 | Stockholm | Sweden |
| 806 | Kaohsiung City | Taiwan |
| 801 | Taichung | Taiwan |
| 800 | Tainan | Taiwan |
| 803 | Taoyuan Hsien | Taiwan |
| 603 | Birmingham | United Kingdom |
| 606 | Cardiff | United Kingdom |
| 601 | Cornwall | United Kingdom |
| 600 | London | United Kingdom |
| 605 | Middlesbrough | United Kingdom |
| 607 | Newcastle | United Kingdom |
| 608 | Salford | United Kingdom |
| 602 | Swansea | United Kingdom |
| Ben-Menachem E, Mameniskiene R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016 Jul 19;87(3):314-23. doi: 10.1212/WNL.0000000000002864. Epub 2016 Jun 22. |
| 26471380 | Result | Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212. Epub 2015 Oct 16. |
| 27589414 | Result | Brodie MJ, Whitesides J, Schiemann J, D'Souza J, Johnson ME. Tolerability, safety, and efficacy of adjunctive brivaracetam for focal seizures in older patients: A pooled analysis from three phase III studies. Epilepsy Res. 2016 Nov;127:114-118. doi: 10.1016/j.eplepsyres.2016.08.018. Epub 2016 Aug 18. |
| 27608437 | Result | Moseley BD, Sperling MR, Asadi-Pooya AA, Diaz A, Elmouft S, Schiemann J, Whitesides J. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Epilepsy Res. 2016 Nov;127:179-185. doi: 10.1016/j.eplepsyres.2016.09.003. Epub 2016 Sep 3. |
| 28236727 | Result | Brandt C, Borghs S, Elmoufti S, Mueller K, Townsend R, de la Loge C. Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis. Epilepsy Behav. 2017 Apr;69:80-85. doi: 10.1016/j.yebeh.2016.11.031. Epub 2017 Feb 23. |
| 27988967 | Result | Klein P, Johnson ME, Schiemann J, Whitesides J. Time to onset of sustained >/=50% responder status in patients with focal (partial-onset) seizures in three phase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017 Feb;58(2):e21-e25. doi: 10.1111/epi.13631. Epub 2016 Dec 18. |
| 28279891 | Result | Asadi-Pooya AA, Sperling MR, Chung S, Klein P, Diaz A, Elmoufti S, Schiemann J, Whitesides J. Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study. Epilepsy Res. 2017 Mar;131:70-75. doi: 10.1016/j.eplepsyres.2017.02.007. Epub 2017 Feb 27. |
| 29414542 | Result | Benbadis S, Klein P, Schiemann J, Diaz A, Elmoufti S, Whitesides J. Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy Behav. 2018 Mar;80:129-134. doi: 10.1016/j.yebeh.2017.12.024. Epub 2018 Feb 3. |
| 29908435 | Result | Brodie MJ, Fakhoury T, McDonough B, Colson AO, Stockis A, Elmoufti S, Whitesides J. Brivaracetam-induced elevation of carbamazepine epoxide levels: A post-hoc analysis from the clinical development program. Epilepsy Res. 2018 Sep;145:55-62. doi: 10.1016/j.eplepsyres.2018.06.002. Epub 2018 Jun 4. |
| 32432339 | Result | Klein P, Laloyaux C, Elmoufti S, Gasalla T, Martin MS. Time course of 75%-100% efficacy response of adjunctive brivaracetam. Acta Neurol Scand. 2020 Aug;142(2):175-180. doi: 10.1111/ane.13287. Epub 2020 Jun 9. |
| 34218211 | Result | Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24. |
| 35582748 | Result | Ryvlin P, Dimova S, Elmoufti S, Floricel F, Laloyaux C, Nondonfaz X, Biton V. Tolerability and efficacy of adjunctive brivaracetam in adults with focal seizures by concomitant antiseizure medication use: Pooled results from three phase 3 trials. Epilepsia. 2022 Aug;63(8):2024-2036. doi: 10.1111/epi.17304. Epub 2022 Jun 10. |
| 36435010 | Derived | Brandt C, Dimova S, Elmoufti S, Laloyaux C, Nondonfaz X, Klein P. Retention, efficacy, tolerability, and quality of life during long-term adjunctive brivaracetam treatment by number of lifetime antiseizure medications: A post hoc analysis of phase 3 trials in adults with focal seizures. Epilepsy Behav. 2023 Jan;138:108967. doi: 10.1016/j.yebeh.2022.108967. Epub 2022 Nov 23. |
| 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. |
| 34155568 | Derived | Lee SK, Heo K, Kim SE, Lee SA, Elmoufti S, Laloyaux C, Hur B. Effect of Number of Previous Antiseizure Medications on Efficacy and Tolerability of Adjunctive Brivaracetam for Uncontrolled Focal Seizures: Post Hoc Analysis. Adv Ther. 2021 Jul;38(7):4082-4099. doi: 10.1007/s12325-021-01816-5. Epub 2021 Jun 21. |
| 33780735 | Derived | Toledo M, Brandt C, Quarato PP, Schulz AL, Cleveland JM, Wagener G, Klein P. Long-term safety, efficacy, and quality of life during adjunctive brivaracetam treatment in patients with uncontrolled epilepsy: An open-label follow-up trial. Epilepsy Behav. 2021 May;118:107897. doi: 10.1016/j.yebeh.2021.107897. Epub 2021 Mar 27. |
| 26899665 | Derived | Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6. |
| FDA Safety Alerts and Recalls | View source |
| FG002 | Brivaracetam 200 mg/Day | Brivaracetam 100 mg administered twice daily |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics consist of the Randomized Set (RS). The RS includes all subjects that were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo tablets administered twice daily |
| BG001 | Brivaracetam 100 mg/Day | Brivaracetam 50 mg administered twice daily |
| BG002 | Brivaracetam 200 mg/Day | Brivaracetam 100 mg administered twice daily |
| BG003 | Total Title |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Median | Standard Deviation | kilograms |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Racial Group | Number | 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 | Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Primary endpoint: United States of America (FDA) | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | Posted | Number | Percentage of reduction | 12 week Treatment Period |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration | Primary Endpoint: European Regulatory Authorities A responder is a participant who experienced a 50% or greater reduction in partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration. | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | Posted | Number | Percentage of subjects | Baseline to 12 week Treatment Period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Partial Onset Seizure (Type I) Frequency From the Baseline to the Treatment Period | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | Posted | Median | Inter-Quartile Range | percentage of change | Baseline to 12 week Treatment Period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Categorized Percent Reduction Form Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the Treatment Period | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | Posted | Number | percentage of subjects | Baseline to 12 week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Seizure Freedom Rate (All Seizure Types) During the 12-week Treatment Period | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | Posted | Number | percentage of subjects | 12 week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | All Seizure Frequency (Type I + II + III) During the 12-week Treatment Period | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | Posted | Median | Inter-Quartile Range | number of seizures/ 28-day | 12 week Treatment Period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to the First Type I Seizure During the Treatment Period | Analysis population consists of the Intent-to-Treat (ITT) Population, which is all randomized subjects who received at least 1 dose of study medication and have at least 1 post-Baseline seizure diary. | Posted | Median | 95% Confidence Interval | days | 12 week Treatment Period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to the Fifth Type I Seizure During the Treatment Period | Posted | Median | 95% Confidence Interval | days | 12 week Treatment Period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to the Tenth Type I Seizure During the Treatment Period | Posted | Median | 95% Confidence Interval | days | 12 week Treatment Period |
|
|
Treatment-emergent Adverse Events (TEAE) were collected during the study up to week 18
TEAEs are comprised of the Safety Population, which consists of all randomized subjects who receive at least 1 dose of study medication.
The Non-serious Adverse Events section represents a >= 5% threshold of subjects experiencing Non-serious TEAEs in any treatment group and not the total population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo tablets administered twice daily | 9 | 261 | 61 | 261 | ||
| EG001 | Brivaracetam 100 mg/Day | Brivaracetam 50 mg administered twice daily | 8 | 253 | 96 | 253 | ||
| EG002 | Brivaracetam 200 mg/Day | Brivaracetam 100 mg administered twice daily | 8 | 250 | 97 | 250 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Sudden unexplained death in epilepsy | General disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Traumatic renal injury | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA15.0 | Non-systematic Assessment |
| |
| Thymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA15.0 | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Seizure cluster | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Postictal state | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
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| Adjustment disorder | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Epileptic psychosis | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA15.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA15.0 | Non-systematic Assessment |
|
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C482793 | brivaracetam |
| D000927 | Anticonvulsants |
| ID | Term |
|---|---|
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
| Male |
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| Asian |
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| Black or African American |
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| White |
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| Other |
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| Missing |
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| ANCOVA |
Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model. |
| <0.001 |
Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure. |
| Percent reduction over PBO |
| 23.2 |
| 2-Sided |
| 95 |
| 13.8 |
| 31.6 |
| Superiority or Other (legacy) |
| Participants |
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