Advertisement

Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures

Sponsored by UCB, Inc.

Phase Quota
Phase 3

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.

Study Start Date: December 2010

Estimated Completion Date: May 2014

Specialties: Neurology: Neuro/Psych pharmacology,Seizure Pharmacy: Drug Trials,Neuro/Psych pharmacology

Interventions

  • Drug: Placebo
  • Drug: Brivaracetam

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

Study Locations And Contact Information

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

Feature this Clinical Trial

Get your trial in front of 1000s of physicians and patients.
Visit ClinicalTrialsLocator.com to find out how you can feature this clinical trial.

Advertisement