Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures
- Conditions
- Epilepsy
- Interventions
- Drug: PlaceboDrug: Antiepileptic drugs with market authorization available per country
- Registration Number
- NCT01261325
- Lead Sponsor
- UCB Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 768
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo tablets administered twice daily Placebo Antiepileptic drugs with market authorization available per country Matching placebo tablets administered twice daily Brivaracetam 100 mg/ day Antiepileptic drugs with market authorization available per country Brivaracetam 50 mg/ day administered twice daily. Brivaracetam 200 mg/ day Antiepileptic drugs with market authorization available per country Brivaracetam 100 mg/ day administered twice daily Brivaracetam 100 mg/ day Brivaracetam Brivaracetam 50 mg/ day administered twice daily. Brivaracetam 200 mg/ day Brivaracetam Brivaracetam 100 mg/ day administered twice daily
- Primary Outcome Measures
Name Time Method Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration 12 week Treatment Period Primary endpoint: United States of America (FDA)
50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration Baseline to 12 week Treatment Period 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.
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (207)
090
🇺🇸Ocala, Florida, United States
006
🇺🇸Tucson, Arizona, United States
044
🇺🇸Sarasota, Florida, United States
071
🇺🇸Miami, Florida, United States
073
🇺🇸Naples, Florida, United States
051
🇺🇸Missoula, Montana, United States
200
🇦🇹Wien, Austria
902
🇩🇪Erlangen, Germany
275
🇫🇮Kuopio, Finland
305
🇫🇷Montpellier, France
329
🇩🇪Berlin, Germany
327
🇩🇪Kiel, Germany
900
🇩🇪Marburg, Germany
852
🇯🇵Itami-city, Japan
382
🇮🇹Torino, Italy
850
🇯🇵Osaka, Japan
411
ðŸ‡ðŸ‡ºBudapest, Hungary
700
ðŸ‡ðŸ‡°Shatin, Hong Kong
384
🇮🇹Reggio Calabria, Italy
851
🇯🇵Shizuoka, Japan
427
🇱🇹Kaunas, Lithuania
125
🇲🇽Distrito Federal, Mexico
793
🇵🇱Krakow, Poland
038
🇵🇷San Juan, Puerto Rico
501
🇷🇺Kazan, Russian Federation
505
🇷🇺Moscow, Russian Federation
482
🇵🇱Poznan, Poland
502
🇷🇺Moscow, Russian Federation
503
🇷🇺Moscow, Russian Federation
509
🇷🇺Nizhny Novgorod, Russian Federation
806
🇨🇳Kaohsiung City, Taiwan
801
🇨🇳Taichung, Taiwan
803
🇨🇳Taoyuan Hsien, Taiwan
064
🇺🇸Port Charlotte, Florida, United States
110
🇺🇸Miami, Florida, United States
025
🇺🇸San Francisco, California, United States
085
🇺🇸Colorado Springs, Colorado, United States
009
🇺🇸Golden Valley, Minnesota, United States
089
🇺🇸Casper, Wyoming, United States
013
🇺🇸Phoenix, Arizona, United States
410
ðŸ‡ðŸ‡ºBudapest, Hungary
412
ðŸ‡ðŸ‡ºBudapest, Hungary
001
🇺🇸Phoenix, Arizona, United States
775
🇺🇸Little Rock, Arkansas, United States
069
🇺🇸Iowa City, Iowa, United States
070
🇺🇸Columbus, Ohio, United States
049
🇺🇸Houston, Texas, United States
091
🇺🇸Oklahoma City, Oklahoma, United States
005
🇺🇸Peoria, Illinois, United States
226
🇧🇪Hechteleksel, Belgium
048
🇺🇸Rome, Georgia, United States
095
🇺🇸Kingston, New York, United States
068
🇺🇸Waldorf, Maryland, United States
021
🇺🇸Port Royal, South Carolina, United States
058
🇺🇸Voorhees, New Jersey, United States
062
🇺🇸Columbus, Georgia, United States
039
🇺🇸Boise, Idaho, United States
023
🇺🇸Atlanta, Georgia, United States
042
🇺🇸Hamilton, New Jersey, United States
022
🇺🇸New York, New York, United States
032
🇺🇸Lebanon, New Hampshire, United States
294
🇧🇬Blagoevrad, Bulgaria
653
🇪🇪Tallinn, Estonia
651
🇪🇪Tartu, Estonia
076
🇨🇦Toronto, Ontario, Canada
099
🇺🇸New York, New York, United States
252
🇨🇿Praha 1, Czechia
034
🇺🇸Cleveland, Ohio, United States
015
🇺🇸Philadelphia, Pennsylvania, United States
003
🇺🇸Durham, North Carolina, United States
098
🇺🇸Poughkeepsie, New York, United States
227
🇧🇪Leuven, Belgium
078
🇨🇦London, Ontario, Canada
054
🇺🇸Tulsa, Oklahoma, United States
096
🇺🇸Canton, Ohio, United States
228
🇧🇪Liege, Belgium
043
🇺🇸Oklahoma City, Oklahoma, United States
052
🇺🇸Madison, Wisconsin, United States
916
🇨🇿Kromeriz, Czechia
202
🇦🇹Innsbruck, Austria
104
🇧🇷Belo Horizonte, Brazil
103
🇧🇷Riberao Preto, Brazil
080
🇨🇦Saskatoon, Saskatchewan, Canada
100
🇧🇷Florianopolis, Brazil
101
🇧🇷Sao Paulo, Brazil
077
🇨🇦Greenfield Park, Quebec, Canada
650
🇪🇪Tallinn, Estonia
652
🇪🇪Tallinn, Estonia
278
🇫🇮Oulu, Finland
287
🇧🇬Sofiya, Bulgaria
075
🇨🇦Calgary, Alberta, Canada
256
🇨🇿Ostrava, Czechia
301
🇫🇷Bethune, France
326
🇩🇪Bernau, Germany
331
🇩🇪Goettingen, Germany
277
🇫🇮Turku, Finland
308
🇫🇷Marseille, France
904
🇩🇪Kehl-Kork, Germany
276
🇫🇮Tampere, Finland
332
🇩🇪Bielefeld, Germany
334
🇩🇪Osnabruck, Germany
413
ðŸ‡ðŸ‡ºKecskemet, Hungary
728
🇮🇳Mumbai, Maharastra, India
377
🇮🇹Monserrato, Cagliari, Italy
386
🇮🇹Napoli, Italy
375
🇮🇹Pisa, Italy
330
🇩🇪Ravensburg, Germany
414
ðŸ‡ðŸ‡ºDebrecen, Hungary
726
🇮🇳Bangalore, India
729
🇮🇳Madurai, India
380
🇮🇹Firenze, Italy
731
🇮🇳Nashik, Maharashtra, India
328
🇩🇪Ulm, Germany
727
🇮🇳Hyderabad, Andhra Pradesh, India
725
🇮🇳Mumbai, Maharastra, India
378
🇮🇹Bari, Italy
376
🇮🇹Perugia, Italy
383
🇮🇹Pozzilli, Italy
752
🇰🇷Gwangju, Korea, Republic of
425
🇱🇹Alytus, Lithuania
601
🇬🇧Cornwall, United Kingdom
855
🇯🇵Hiroshima, Japan
854
🇯🇵Yokohama-City, Japan
753
🇰🇷Busan, Korea, Republic of
627
🇱🇻Daugapils, Latvia
629
🇱🇻Jekabpils, Latvia
400
🇳🇱Heeze, Netherlands
126
🇲🇽Guadalajara, Jalisco, Mexico
750
🇰🇷Seoul, Korea, Republic of
625
🇱🇻Valmiera, Latvia
129
🇲🇽Aguascalientes, Mexico
130
🇲🇽Mexico D.F., Mexico
477
🇵🇱Poznan, Poland
508
🇷🇺Smolensk, Russian Federation
751
🇰🇷Seoul, Korea, Republic of
626
🇱🇻Riga, Latvia
628
🇱🇻Riga, Latvia
127
🇲🇽Culiacan, Mexico
537
🇪🇸Valencia, Spain
403
🇳🇱Zwolle, Netherlands
791
🇵🇱Gdansk, Poland
481
🇵🇱Katowice, Poland
552
🇸🇪Linkoping, Sweden
606
🇬🇧Cardiff, United Kingdom
754
🇰🇷Seoul, Korea, Republic of
401
🇳🇱Heemstede, Netherlands
475
🇵🇱Bialystok, Poland
485
🇵🇱Gdansk, Poland
480
🇵🇱Katowice, Poland
476
🇵🇱Krakow, Poland
536
🇪🇸Badalona, Spain
478
🇵🇱Katowice, Poland
479
🇵🇱Poznan, Poland
800
🇨🇳Tainan, Taiwan
540
🇪🇸Barcelona, Spain
600
🇬🇧London, United Kingdom
603
🇬🇧Birmingham, United Kingdom
529
🇪🇸Barcelona, Spain
605
🇬🇧Middlesborough, United Kingdom
607
🇬🇧Newcastle, United Kingdom
608
🇬🇧Salford, United Kingdom
602
🇬🇧Swansea, United Kingdom
539
🇪🇸San Sebastian, Spain
527
🇪🇸Valencia, Spain
532
🇪🇸Santiago de Compostela, Spain
528
🇪🇸Barcelona, Spain
020
🇺🇸Ames, Iowa, United States
063
🇺🇸Atlanta, Georgia, United States
010
🇺🇸Asheville, North Carolina, United States
061
🇺🇸Austin, Texas, United States
002
🇺🇸Toledo, Ohio, United States
050
🇺🇸Arlington, Texas, United States
035
🇺🇸Dallas, Texas, United States
033
🇺🇸Seattle, Washington, United States
253
🇨🇿Praha 4, Czechia
250
🇨🇿Zlin, Czechia
913
🇨🇿Ostrava Poruba, Czechia
060
🇺🇸Aurora, Colorado, United States
045
🇺🇸Sacramento, California, United States
027
🇺🇸Orlando, Florida, United States
017
🇺🇸Winfield, Illinois, United States
092
🇺🇸Hammond, Louisiana, United States
780
🇺🇸Lexington, Kentucky, United States
055
🇺🇸East Lansing, Michigan, United States
008
🇺🇸Bethesda, Maryland, United States
203
🇦🇹Wien, Austria
056
🇺🇸Spokane, Washington, United States
057
🇺🇸Milwaukee, Wisconsin, United States
011
🇺🇸Dallas, Texas, United States
201
🇦🇹Linz, Austria
286
🇧🇬Sofiya, Bulgaria
036
🇺🇸Charlottesville, Virginia, United States
079
🇨🇦Montreal, Quebec, Canada
251
🇨🇿Ostrava, Czechia
335
🇩🇪Muenchen, Germany
379
🇮🇹Milano, Italy
426
🇱🇹Vilnius, Lithuania
483
🇵🇱Lublin, Poland
128
🇲🇽Guadalajara, Jalisco, Mexico
488
🇵🇱Warszawa, Poland
551
🇸🇪Goteborg, Sweden
526
🇪🇸Valladolid, Spain
506
🇷🇺Kazan, Russian Federation
550
🇸🇪Stockholm, Sweden
535
🇪🇸Barcelona, Spain
028
🇺🇸Charleston, South Carolina, United States
701
ðŸ‡ðŸ‡°Hong Kong, Hong Kong