Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures (BRITE™)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01261325
First received: December 9, 2010
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Placebo
Drug: Brivaracetam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Percent reduction over placebo for partial onset seizure (Type I) frequency over the Treatment Period standardized to a 28-day duration [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 12 week Treatment Period ] [ Designated as safety issue: No ]
    Primary Endpoint: European Regulatory Authorities


Secondary Outcome Measures:
  • Percent reduction in partial onset seizure (Type I) frequency from the Baseline to the Treatment Period [ Time Frame: Baseline to 12 week Treatment Period ] [ Designated as safety issue: No ]
  • Categorized percent reduction form Baseline in seizure frequency for partial onset seizure (Type I) over the Treatment Period [ Time Frame: Baseline to 12 week Treatment Period ] [ Designated as safety issue: No ]
  • Seizure freedom rate (all seizure types) during the 12-week Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
  • All seizure frequency (Type I + II + III) during the 12-week Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
  • Time to the first Type I seizure during the Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
  • Time to the fifth Type I seizure during the Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]
  • Time to the tenth Type I seizure during the Treatment Period [ Time Frame: 12 week Treatment Period ] [ Designated as safety issue: No ]

Enrollment: 768
Study Start Date: December 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo tablets administered twice daily
Drug: Placebo
Daily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period
Experimental: Brivaracetam 100 mg/ day
Brivaracetam 50 mg/ day administered twice daily.
Drug: Brivaracetam
Daily oral dose of two equal intakes of Brivaracetam 100 mg/ day in a double-blinded way for the 12-week treatment period
Experimental: Brivaracetam 200 mg/ day
Brivaracetam 100 mg/ day administered twice daily
Drug: Brivaracetam
Daily oral dose of two equal intakes of Brivaracetam 200 mg/ day in a double-blinded way for the 12-week treatment period.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261325

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Locations
United States, Arizona
013
Phoenix, Arizona, United States
001
Phoenix, Arizona, United States
006
Tucson, Arizona, United States
United States, Arkansas
775
Little Rock, Arkansas, United States
United States, California
045
Sacramento, California, United States
025
San Francisco, California, United States
United States, Colorado
060
Aurora, Colorado, United States
085
Colorado Springs, Colorado, United States
United States, Florida
110
Miami, Florida, United States
071
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
United States, Georgia
023
Atlanta, Georgia, United States
063
Atlanta, Georgia, United States
062
Columbus, Georgia, United States
048
Rome, Georgia, United States
United States, Idaho
039
Boise, Idaho, United States
United States, Illinois
005
Peoria, Illinois, United States
017
Winfield, Illinois, United States
United States, Iowa
020
Ames, Iowa, United States
069
Iowa City, Iowa, United States
United States, Kentucky
780
Lexington, Kentucky, United States
United States, Louisiana
092
Hammond, Louisiana, United States
United States, Maryland
008
Bethesda, Maryland, United States
068
Waldorf, Maryland, United States
United States, Michigan
055
East Lansing, Michigan, United States
United States, Minnesota
009
Golden Valley, Minnesota, United States
United States, Montana
051
Missoula, Montana, United States
United States, Nebraska
094
Omaha, Nebraska, United States
United States, New Hampshire
032
Lebanon, New Hampshire, United States
United States, New Jersey
042
Hamilton, New Jersey, United States
058
Voorhees, New Jersey, United States
United States, New York
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
United States, North Carolina
010
Asheville, North Carolina, United States
003
Durham, North Carolina, United States
United States, Ohio
096
Canton, Ohio, United States
034
Cleveland, Ohio, United States
070
Columbus, Ohio, United States
002
Toledo, Ohio, United States
United States, Oklahoma
043
Oklahoma City, Oklahoma, United States
091
Oklahoma City, Oklahoma, United States
054
Tulsa, Oklahoma, United States
United States, Pennsylvania
015
Philadelphia, Pennsylvania, United States
United States, South Carolina
028
Charleston, South Carolina, United States
021
Port Royal, South Carolina, United States
United States, Texas
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
United States, Virginia
036
Charlottesville, Virginia, United States
United States, Washington
033
Seattle, Washington, United States
056
Spokane, Washington, United States
United States, Wisconsin
052
Madison, Wisconsin, United States
057
Milwaukee, Wisconsin, United States
United States, Wyoming
089
Casper, Wyoming, United States
Austria
202
Innsbruck, Austria
201
Linz, Austria
203
Wien, Austria
200
Wien, Austria
Belgium
226
Hechteleksel, Belgium
227
Leuven, Belgium
228
Liege, Belgium
Brazil
104
Belo Horizonte, Brazil
100
Florianopolis, Brazil
103
Riberao Preto, Brazil
101
Sao Paulo, Brazil
Bulgaria
294
Blagoevrad, Bulgaria
287
Sofiya, Bulgaria
286
Sofiya, Bulgaria
Canada, Alberta
075
Calgary, Alberta, Canada
Canada, Ontario
078
London, Ontario, Canada
076
Toronto, Ontario, Canada
Canada, Quebec
077
Greenfield Park, Quebec, Canada
079
Montreal, Quebec, Canada
Canada, Saskatchewan
080
Saskatoon, Saskatchewan, Canada
Czech Republic
916
Kromeriz, Czech Republic
256
Ostrava, Czech Republic
251
Ostrava, Czech Republic
913
Ostrava Poruba, Czech Republic
252
Praha 1, Czech Republic
253
Praha 4, Czech Republic
250
Zlin, Czech Republic
Estonia
652
Tallinn, Estonia
653
Tallinn, Estonia
650
Tallinn, Estonia
651
Tartu, Estonia
Finland
275
Kuopio, Finland
278
Oulu, Finland
276
Tampere, Finland
277
Turku, Finland
France
301
Bethune, France
308
Marseille, France
305
Montpellier, France
Germany
329
Berlin, Germany
326
Bernau, Germany
332
Bielefeld, Germany
902
Erlangen, Germany
331
Goettingen, Germany
904
Kehl-Kork, Germany
327
Kiel, Germany
900
Marburg, Germany
335
Muenchen, Germany
334
Osnabruck, Germany
330
Ravensburg, Germany
328
Ulm, Germany
Hong Kong
701
Hong Kong, Hong Kong
700
Shatin, Hong Kong
Hungary
410
Budapest, Hungary
412
Budapest, Hungary
411
Budapest, Hungary
414
Debrecen, Hungary
413
Kecskemet, Hungary
India
727
Hyderabad, Andhra Pradesh, India
731
Nashik, Maharashtra, India
725
Mumbai, Maharastra, India
728
Mumbai, Maharastra, India
726
Bangalore, India
729
Madurai, India
Italy
377
Monserrato, Cagliari, Italy
378
Bari, Italy
380
Firenze, Italy
379
Milano, Italy
386
Napoli, Italy
376
Perugia, Italy
375
Pisa, Italy
383
Pozzilli, Italy
384
Reggio Calabria, Italy
382
Torino, Italy
Japan
855
Hiroshima, Japan
852
Itami-city, Japan
850
Osaka, Japan
851
Shizuoka, Japan
854
Yokohama-City, Japan
Korea, Republic of
753
Busan, Korea, Republic of
752
Gwangju, Korea, Republic of
751
Seoul, Korea, Republic of
754
Seoul, Korea, Republic of
750
Seoul, Korea, Republic of
Latvia
627
Daugapils, Latvia
629
Jekabpils, Latvia
628
Riga, Latvia
626
Riga, Latvia
625
Valmiera, Latvia
Lithuania
425
Alytus, Lithuania
427
Kaunas, Lithuania
426
Vilnius, Lithuania
Mexico
128
Guadalajara, Jalisco, Mexico
126
Guadalajara, Jalisco, Mexico
129
Aguascalientes, Mexico
127
Culiacan, Mexico
125
Distrito Federal, Mexico
130
Mexico D.F., Mexico
Netherlands
401
Heemstede, Netherlands
400
Heeze, Netherlands
403
Zwolle, Netherlands
Poland
475
Bialystok, Poland
485
Gdansk, Poland
791
Gdansk, Poland
478
Katowice, Poland
481
Katowice, Poland
480
Katowice, Poland
476
Krakow, Poland
793
Krakow, Poland
483
Lublin, Poland
482
Poznan, Poland
477
Poznan, Poland
479
Poznan, Poland
488
Warszawa, Poland
Puerto Rico
038
San Juan, Puerto Rico
Russian Federation
501
Kazan, Russian Federation
506
Kazan, Russian Federation
503
Moscow, Russian Federation
505
Moscow, Russian Federation
502
Moscow, Russian Federation
509
Nizhny Novgorod, Russian Federation
508
Smolensk, Russian Federation
Spain
536
Badalona, Spain
528
Barcelona, Spain
535
Barcelona, Spain
540
Barcelona, Spain
529
Barcelona, Spain
539
San Sebastian, Spain
532
Santiago de Compostela, Spain
537
Valencia, Spain
527
Valencia, Spain
526
Valladolid, Spain
Sweden
551
Goteborg, Sweden
552
Linkoping, Sweden
550
Stockholm, Sweden
Taiwan
806
Kaohsiung City, Taiwan
801
Taichung, Taiwan
800
Tainan, Taiwan
803
Taoyuan Hsien, Taiwan
United Kingdom
603
Birmingham, United Kingdom
606
Cardiff, United Kingdom
601
Cornwall, United Kingdom
600
London, United Kingdom
605
Middlesborough, United Kingdom
607
Newcastle, United Kingdom
608
Salford, United Kingdom
602
Swansea, United Kingdom
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01261325     History of Changes
Other Study ID Numbers: N01358, 2010-019361-28
Study First Received: December 9, 2010
Last Updated: May 29, 2014
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Canada: Health Canada
Mexico: Federal Commission for Protection Against Health Risks
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Finland: Ministry of Social Affairs and Health
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Italy: Ministry of Health
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Ministry of Health and Consumption
Sweden: The National Board of Health and Welfare
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by UCB Pharma:
Epilepsy
Brivaracetam
Partial Onset Seizures
Adjunctive treatment

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014