Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
NCT ID: NCT01339559
Last Updated: 2021-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
767 participants
INTERVENTIONAL
2011-05-11
2019-04-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brivaracetam
Brivaracetam with a maximum of 200 mg/day
Brivaracetam
Tablet, Flexible dosing up to 200 mg/day, twice daily.
The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.
Interventions
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Brivaracetam
Tablet, Flexible dosing up to 200 mg/day, twice daily.
The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
* Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
* Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible
Exclusion Criteria
* Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
* Poor compliance with the visit schedule or medication intake in the previous BRV study
* Planned participation in any other clinical study of another investigational drug or device during this study
* Pregnant or lactating woman
* Any medical condition which, in the Investigator's opinion, warrants exclusion
* Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
16 Years
ALL
No
Sponsors
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UCB BIOSCIENCES, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273 (UCB)
Locations
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001
Phoenix, Arizona, United States
013
Phoenix, Arizona, United States
006
Tucson, Arizona, United States
775
Little Rock, Arkansas, United States
025
San Francisco, California, United States
060
Aurora, Colorado, United States
071
Miami, Florida, United States
027
Orlando, Florida, United States
064
Port Charlotte, Florida, United States
023
Atlanta, Georgia, United States
048
Rome, Georgia, United States
039
Boise, Idaho, United States
029
Chicago, Illinois, 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
008
Bethesda, Maryland, United States
068
Waldorf, Maryland, United States
009
Golden Valley, Minnesota, United States
032
Lebanon, New Hampshire, United States
042
Hamilton, New Jersey, United States
099
New York, New York, United States
022
New York, New York, United States
098
Poughkeepsie, New York, United States
010
Asheville, North Carolina, United States
003
Durham, North Carolina, United States
034
Cleveland, Ohio, United States
778
Columbus, 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
776
Nashville, Tennessee, United States
061
Austin, Texas, United States
011
Dallas, Texas, United States
777
Dallas, Texas, United States
035
Dallas, Texas, United States
049
Houston, Texas, United States
050
Mansfield, Texas, United States
036
Charlottesville, Virginia, United States
056
Spokane, Washington, United States
052
Madison, Wisconsin, United States
057
Milwaukee, Wisconsin, United States
202
Innsbruck, , Austria
201
Linz, , Austria
203
Vienna, , Austria
226
Hechtel-Eksel, , Belgium
227
Leuven, , Belgium
104
Belo Horizonte, , Brazil
100
Florianópolis, , Brazil
101
São Paulo, , Brazil
294
Blagoevgrad, , Bulgaria
286
Sofia, , Bulgaria
287
Sofia, , Bulgaria
075
Calgary, Alberta, Canada
078
London, Ontario, Canada
076
Toronto, Ontario, Canada
077
Greenfield Park, Quebec, Canada
080
Saskatoon, Saskatchewan, Canada
079
Montreal, , Canada
917
Brno, , Czechia
916
Kroměříž, , Czechia
251
Ostrava, , Czechia
256
Ostrava, , Czechia
913
Ostrava Poruba, , Czechia
252
Prague, , Czechia
253
Prague, , Czechia
250
Zlín, , Czechia
650
Tallinn, , Estonia
652
Tallinn, , Estonia
651
Tartu, , Estonia
275
Kuopio, , Finland
276
Tampere, , Finland
301
Béthune, , France
305
Montpellier, , France
329
Berlin, , Germany
326
Bernau, , Germany
332
Bielefeld, , Germany
902
Erlangen, , Germany
331
Göttingen, , Germany
327
Kiel, , Germany
900
Marburg, , Germany
335
München, , Germany
334
Osnabrück, , Germany
330
Ravensburg, , Germany
328
Ulm, , Germany
700
Hong Kong, , Hong Kong
701
Hong Kong, , Hong Kong
410
Budapest, , Hungary
411
Budapest, , Hungary
412
Budapest, , Hungary
414
Hajdú-Bihar, , Hungary
413
Szekszárd, , Hungary
731
Nashik, Maharashtra, India
726
Bangalore, , India
727
Hyderabad, , India
729
Madurai, , India
725
Mumbai, , India
728
Mumbai, , India
378
Bari, , Italy
380
Florence, , Italy
379
Milan, , Italy
377
Monserrato, , Italy
386
Napoli, , Italy
376
Perugia, , Italy
375
Pisa, , Italy
383
Pozzilli, , Italy
384
Reggio Calabria, , Italy
852
Itami, Hyōgo, Japan
855
Hiroshima, , Japan
850
Osaka, , Japan
851
Shizuoka, , Japan
854
Yokohama, , Japan
627
Daugavpils, , Latvia
629
Jēkabpils, , 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
795
Katowice, , Poland
476
Krakow, , Poland
793
Krakow, , Poland
483
Lublin, , Poland
477
Poznan, , Poland
479
Poznan, , Poland
482
Poznan, , Poland
488
Warsaw, , Poland
794
Warsaw, , Poland
038
San Juan, , Puerto Rico
501
Kazan', , Russia
506
Kazan', , Russia
502
Moscow, , Russia
503
Moscow, , Russia
509
Nizhny Novgorod, , Russia
508
Smolensk, , Russia
753
Busan, , South Korea
750
Seoul, , South Korea
751
Seoul, , South Korea
754
Seoul, , South Korea
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 City, , Taiwan
803
Taoyuan District, , Taiwan
602
Morriston, Swansea, United Kingdom
603
Birmingham, , United Kingdom
600
London, , United Kingdom
605
Middlesbrough, , United Kingdom
607
Newcastle, , United Kingdom
608
Salford, , United Kingdom
601
Truro, , United Kingdom
Countries
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References
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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.
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.
Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Product Information
FDA Safety Alerts and Recalls
Other Identifiers
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2010-020345-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01379
Identifier Type: -
Identifier Source: org_study_id
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