Clinical trial NCT01339559: Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
Official title: An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
Brivaracetam
Partial Onset Seizures
Adjunctive treatment
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-04-20
Enrollment: 767
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).

Detailed description: The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.

Eligibility criteria: Inclusion Criteria:

* Subject completed the Treatment Period of N01358 or the evaluation period of N01258
* 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:

* Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
* 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

Primary outcomes:
measure: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
measure: Percentage of Participants Who Withdrew Due to Adverse Events (AEs)
timeFrame: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
measure: Percentage of Participants With at Least One Serious Adverse Event (SAE)
timeFrame: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Secondary outcomes:
measure: Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
timeFrame: From Baseline of the previous study until the Last Visit (up to 84 months)
measure: Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
timeFrame: From Baseline of the previous study until the Last Visit (up to 84 months)
measure: Responder Rate in POS (Type I) Frequency Over the Evaluation Period
timeFrame: From Baseline of the previous study until the Last Visit (up to 84 months)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 001
state: Arizona
city: Phoenix
country: United States
facility: 013
state: Arizona
city: Tucson
country: United States
facility: 006
state: Arizona
city: Little Rock
country: United States
facility: 775
state: Arkansas
city: San Francisco
country: United States
facility: 025
state: California
city: Aurora
country: United States
facility: 060
state: Colorado
city: Miami
country: United States
facility: 071
state: Florida
city: Orlando
country: United States
facility: 027
state: Florida
city: Port Charlotte
country: United States
facility: 064
state: Florida
city: Atlanta
country: United States
facility: 023
state: Georgia
city: Rome
country: United States
facility: 048
state: Georgia
city: Boise
country: United States
facility: 039
state: Idaho
city: Chicago
country: United States
facility: 029
state: Illinois
city: Peoria
country: United States
facility: 005
state: Illinois
city: Winfield
country: United States
facility: 017
state: Illinois
city: Ames
country: United States
facility: 020
state: Iowa
city: Iowa City
country: United States
facility: 069
state: Iowa
city: Lexington
country: United States
facility: 780
state: Kentucky
city: Bethesda
country: United States
facility: 008
state: Maryland
city: Waldorf
country: United States
facility: 068
state: Maryland
city: Golden Valley
country: United States
facility: 009
state: Minnesota
city: Lebanon
country: United States
facility: 032
state: New Hampshire
city: Hamilton
country: United States
facility: 042
state: New Jersey
city: New York
country: United States
facility: 099
state: New York
city: New York
country: United States
facility: 022
state: New York
city: Poughkeepsie
country: United States
facility: 098
state: New York
city: Asheville
country: United States
facility: 010
state: North Carolina
city: Durham
country: United States
facility: 003
state: North Carolina
city: Cleveland
country: United States
facility: 034
state: Ohio
city: Columbus
country: United States
facility: 778
state: Ohio
city: Columbus
country: United States
facility: 070
state: Ohio
city: Toledo
country: United States
facility: 002
state: Ohio
city: Oklahoma City
country: United States
facility: 043
state: Oklahoma
city: Oklahoma City
country: United States
facility: 091
state: Oklahoma
city: Tulsa
country: United States
facility: 054
state: Oklahoma
city: Philadelphia
country: United States
facility: 015
state: Pennsylvania
city: Charleston
country: United States
facility: 028
state: South Carolina
city: Port Royal
country: United States
facility: 021
state: South Carolina
city: Nashville
country: United States
facility: 776
state: Tennessee
city: Austin
country: United States
facility: 061
state: Texas
city: Dallas
country: United States
facility: 011
state: Texas
city: Dallas
country: United States
facility: 777
state: Texas
city: Dallas
country: United States
facility: 035
state: Texas
city: Houston
country: United States
facility: 049
state: Texas
city: Mansfield
country: United States
facility: 050
state: Texas
city: Charlottesville
country: United States
facility: 036
state: Virginia
city: Spokane
country: United States
facility: 056
state: Washington
city: Madison
country: United States
facility: 052
state: Wisconsin
city: Milwaukee
country: United States
facility: 057
state: Wisconsin
city: Innsbruck
country: Austria
facility: 202
city: Linz
country: Austria
facility: 201
city: Wien
country: Austria
facility: 203
city: Hechtel-Eksel
country: Belgium
facility: 226
city: Leuven
country: Belgium
facility: 227
city: Belo Horizonte
country: Brazil
facility: 104
city: Florianopolis
country: Brazil
facility: 100
city: Sao Paulo
country: Brazil
facility: 101
city: Blagoevgrad
country: Bulgaria
facility: 294
city: Sofia
country: Bulgaria
facility: 286
city: Sofia
country: Bulgaria
facility: 287
city: Calgary
country: Canada
facility: 075
state: Alberta
city: London
country: Canada
facility: 078
state: Ontario
city: Toronto
country: Canada
facility: 076
state: Ontario
city: Greenfield Park
country: Canada
facility: 077
state: Quebec
city: Saskatoon
country: Canada
facility: 080
state: Saskatchewan
city: Montreal
country: Canada
facility: 079
city: Brno
country: Czechia
facility: 917
city: Kromeriz
country: Czechia
facility: 916
city: Ostrava Poruba
country: Czechia
facility: 913
city: Ostrava
country: Czechia
facility: 251
city: Ostrava
country: Czechia
facility: 256
city: Praha 1
country: Czechia
facility: 252
city: Praha 4
country: Czechia
facility: 253
city: Zlin
country: Czechia
facility: 250
city: Tallinn
country: Estonia
facility: 650
city: Tallinn
country: Estonia
facility: 652
city: Tartu
country: Estonia
facility: 651
city: Kuopio
country: Finland
facility: 275
city: Tampere
country: Finland
facility: 276
city: Bethune
country: France
facility: 301
city: Montpellier
country: France
facility: 305
city: Berlin
country: Germany
facility: 329
city: Bernau
country: Germany
facility: 326
city: Bielefeld
country: Germany
facility: 332
city: Erlangen
country: Germany
facility: 902
city: Göttingen
country: Germany
facility: 331
city: Kiel
country: Germany
facility: 327
city: Marburg
country: Germany
facility: 900
city: Muenchen
country: Germany
facility: 335
city: Osnabruck
country: Germany
facility: 334
city: Ravensburg
country: Germany
facility: 330
city: Ulm
country: Germany
facility: 328
city: Hong Kong
country: Hong Kong
facility: 700
city: Hong Kong
country: Hong Kong
facility: 701
city: Budapest
country: Hungary
facility: 410
city: Budapest
country: Hungary
facility: 411
city: Budapest
country: Hungary
facility: 412
city: Hajdú-Bihar
country: Hungary
facility: 414
city: Szekszard
country: Hungary
facility: 413
city: Nashik
country: India
facility: 731
state: Maharashtra
city: Bangalore
country: India
facility: 726
city: Hyderabad
country: India
facility: 727
city: Madurai
country: India
facility: 729
city: Mumbai
country: India
facility: 725
city: Mumbai
country: India
facility: 728
city: Bari
country: Italy
facility: 378
city: Firenze
country: Italy
facility: 380
city: Milano
country: Italy
facility: 379
city: Monserrato
country: Italy
facility: 377
city: Napoli
country: Italy
facility: 386
city: Perugia
country: Italy
facility: 376
city: Pisa
country: Italy
facility: 375
city: Pozzilli
country: Italy
facility: 383
city: Reggio Calabria
country: Italy
facility: 384
city: Itami
country: Japan
facility: 852
state: Hyogo
city: Hiroshima
country: Japan
facility: 855
city: Osaka
country: Japan
facility: 850
city: Shizuoka
country: Japan
facility: 851
city: Yokohama-City
country: Japan
facility: 854
city: Busan
country: Korea, Republic of
facility: 753
city: Seoul
country: Korea, Republic of
facility: 750
city: Seoul
country: Korea, Republic of
facility: 751
city: Seoul
country: Korea, Republic of
facility: 754
city: Daugavpils
country: Latvia
facility: 627
city: Jekabpils
country: Latvia
facility: 629
city: Riga
country: Latvia
facility: 628
city: Valmiera
country: Latvia
facility: 625
city: Alytus
country: Lithuania
facility: 425
city: Kaunas
country: Lithuania
facility: 427
city: Vilnius
country: Lithuania
facility: 426
city: Guadalajara
country: Mexico
facility: 126
state: Jalisco
city: Guadalajara
country: Mexico
facility: 128
state: Jalisco
city: Aguascalientes
country: Mexico
facility: 129
city: Culiacan
country: Mexico
facility: 127
city: Distrito Federal
country: Mexico
facility: 125
city: Mexico City
country: Mexico
facility: 130
city: Heemstede
country: Netherlands
facility: 401
city: Heeze
country: Netherlands
facility: 400
city: Zwolle
country: Netherlands
facility: 403
city: Bialystok
country: Poland
facility: 475
city: Gdansk
country: Poland
facility: 485
city: Gdansk
country: Poland
facility: 791
city: Katowice
country: Poland
facility: 478
city: Katowice
country: Poland
facility: 480
city: Katowice
country: Poland
facility: 481
city: Katowice
country: Poland
facility: 795
city: Krakow
country: Poland
facility: 476
city: Krakow
country: Poland
facility: 793
city: Lublin
country: Poland
facility: 483
city: Poznan
country: Poland
facility: 477
city: Poznan
country: Poland
facility: 479
city: Poznan
country: Poland
facility: 482
city: Warszawa
country: Poland
facility: 488
city: Warszawa
country: Poland
facility: 794
city: San Juan
country: Puerto Rico
facility: 038
city: Kazan
country: Russian Federation
facility: 501
city: Kazan
country: Russian Federation
facility: 506
city: Moscow
country: Russian Federation
facility: 502
city: Moscow
country: Russian Federation
facility: 503
city: Nizhny Novgorod
country: Russian Federation
facility: 509
city: Smolensk
country: Russian Federation
facility: 508
city: Barcelona
country: Spain
facility: 528
city: Barcelona
country: Spain
facility: 529
city: Barcelona
country: Spain
facility: 535
city: Barcelona
country: Spain
facility: 540
city: San Sebastian
country: Spain
facility: 539
city: Santiago de Compostela
country: Spain
facility: 532
city: Valencia
country: Spain
facility: 527
city: Valencia
country: Spain
facility: 537
city: Valladolid
country: Spain
facility: 526
city: Goteborg
country: Sweden
facility: 551
city: Linkoping
country: Sweden
facility: 552
city: Stockholm
country: Sweden
facility: 550
city: Kaohsiung City
country: Taiwan
facility: 806
city: Taichung
country: Taiwan
facility: 801
city: Tainan
country: Taiwan
facility: 800
city: Taoyuan
country: Taiwan
facility: 803
city: Morriston
country: United Kingdom
facility: 602
state: Swansea
city: Birmingham
country: United Kingdom
facility: 603
city: London
country: United Kingdom
facility: 600
city: Middlesborough
country: United Kingdom
facility: 605
city: Newcastle
country: United Kingdom
facility: 607
city: Salford
country: United Kingdom
facility: 608
city: Truro
country: United Kingdom
facility: 601
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
citation: 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.