Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures
BRITE
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥16 to 80 Years Old) With Partial Onset Seizures
2 other identifiers
interventional
768
27 countries
203
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2010
Typical duration for phase_3
203 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 9, 2010
CompletedFirst Posted
Study publicly available on registry
December 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
August 15, 2016
CompletedJuly 22, 2022
July 1, 2022
3.4 years
December 9, 2010
March 14, 2016
July 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (7)
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
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
- +2 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORMatching placebo tablets administered twice daily
Brivaracetam 100 mg/ day
EXPERIMENTALBrivaracetam 50 mg/ day administered twice daily.
Brivaracetam 200 mg/ day
EXPERIMENTALBrivaracetam 100 mg/ day administered twice daily
Interventions
Daily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period
Daily oral dose of two equal intakes of Brivaracetam 100 mg/ day in a double-blinded way for the 12-week treatment period
Eligibility Criteria
You may qualify if:
- Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification
- Presence of an EEG reading compatible with the clinical diagnosis of focal epilepsy within the last 5 years
- Presence of a brain MRI/computed tomography (CT) scan performed within the last 2 years
- Subjects having at least 8 Type I seizures \[POS; focal seizures (according to the 1981 ILAE classification)\] during the 8-week Baseline Period with at least 2 Type I seizures during each 4-week interval of the Baseline Period
- Subjects having at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1
- Subjects being uncontrolled while treated by 1 or 2 permitted concomitant AED(s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
- Permitted concomitant AED(s) and VNS being stable and at optimal dosage for the subject from at least 1 month (3 months for phenobarbital, phenytoin, and primidone) before V1 and expected to be kept stable during the Baseline and Treatment Period. Benzodiazepine taken more than once a week (for any indication) will be considered as a concomitant AED
You may not qualify if:
- Subject previously randomized within this study or any other prior study with BRV as a dosing arm
- Seizure type IA (1981 ILAE classification) nonmotor as only seizure type.
- Subject is currently treated with LEV or has taken LEV within 90 days prior to V1
- Subject has any medical or psychiatric condition, obvious cognitive impairment or mental retardation that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
- Subjects whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)
- Subject has history or presence of status epilepticus during the year preceding V1 or during Baseline
- Subject has history or presence of known psychogenic nonepileptic seizures
- Subject on felbamate with less than 18 months exposure before V1
- Subject currently on vigabatrin. Subject with history of vigabatrin use but either no visual fields examination report available including standard static (Humphrey or Octopus) or kinetic perimetry (Goldman) or results of these examinations are abnormal
- Subject taking any drug with possible central nervous system (CNS) effects except if stable from at least 1 month before V1 and expected to be kept stable during the Treatment Period
- Subject has history of cerebrovascular accident, including transient ischemic attack, in the last 6 months
- Subject is suffering from severe cardiovascular disease or peripheral vascular disease
- Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
- Subject has ongoing psychiatric disease other than mild controlled disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (207)
001
Phoenix, Arizona, United States
013
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
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
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
Napoli, 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
Related Publications (18)
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.
PMID: 27265725RESULTBen-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.
PMID: 27335114RESULTKlein 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.
PMID: 26471380RESULTBrodie 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.
PMID: 27589414RESULTMoseley 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.
PMID: 27608437RESULTBrandt 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.
PMID: 28236727RESULTKlein 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.
PMID: 27988967RESULTAsadi-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.
PMID: 28279891RESULTBenbadis 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.
PMID: 29414542RESULTBrodie 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.
PMID: 29908435RESULTKlein 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.
PMID: 32432339RESULTMoseley 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.
PMID: 34218211RESULTRyvlin 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.
PMID: 35582748RESULTBrandt 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.
PMID: 36435010DERIVEDBresnahan 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.
PMID: 35285519DERIVEDLee 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.
PMID: 34155568DERIVEDToledo 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.
PMID: 33780735DERIVEDMarkham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
PMID: 26899665DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 9, 2010
First Posted
December 16, 2010
Study Start
December 1, 2010
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
July 22, 2022
Results First Posted
August 15, 2016
Record last verified: 2022-07