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Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy (BRITE™)

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brivaracetam
Sponsored by
UCB BIOSCIENCES, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Brivaracetam, Partial Onset Seizures, Adjunctive treatment

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 001
  • 013
  • 006
  • 775
  • 025
  • 060
  • 071
  • 027
  • 064
  • 023
  • 048
  • 039
  • 029
  • 005
  • 017
  • 020
  • 069
  • 780
  • 008
  • 068
  • 009
  • 032
  • 042
  • 099
  • 022
  • 098
  • 010
  • 003
  • 034
  • 778
  • 070
  • 002
  • 043
  • 091
  • 054
  • 015
  • 028
  • 021
  • 776
  • 061
  • 011
  • 777
  • 035
  • 049
  • 050
  • 036
  • 056
  • 052
  • 057
  • 202
  • 201
  • 203
  • 226
  • 227
  • 104
  • 100
  • 101
  • 294
  • 286
  • 287
  • 075
  • 078
  • 076
  • 077
  • 080
  • 079
  • 917
  • 916
  • 913
  • 251
  • 256
  • 252
  • 253
  • 250
  • 650
  • 652
  • 651
  • 275
  • 276
  • 301
  • 305
  • 329
  • 326
  • 332
  • 902
  • 331
  • 327
  • 900
  • 335
  • 334
  • 330
  • 328
  • 700
  • 701
  • 410
  • 411
  • 412
  • 414
  • 413
  • 731
  • 726
  • 727
  • 729
  • 725
  • 728
  • 378
  • 380
  • 379
  • 377
  • 386
  • 376
  • 375
  • 383
  • 384
  • 852
  • 855
  • 850
  • 851
  • 854
  • 753
  • 750
  • 751
  • 754
  • 627
  • 629
  • 628
  • 625
  • 425
  • 427
  • 426
  • 126
  • 128
  • 129
  • 127
  • 125
  • 130
  • 401
  • 400
  • 403
  • 475
  • 485
  • 791
  • 478
  • 480
  • 481
  • 795
  • 476
  • 793
  • 483
  • 477
  • 479
  • 482
  • 488
  • 794
  • 038
  • 501
  • 506
  • 502
  • 503
  • 509
  • 508
  • 528
  • 529
  • 535
  • 540
  • 539
  • 532
  • 527
  • 537
  • 526
  • 551
  • 552
  • 550
  • 806
  • 801
  • 800
  • 803
  • 602
  • 603
  • 600
  • 605
  • 607
  • 608
  • 601

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brivaracetam

Arm Description

Brivaracetam with a maximum of 200 mg/day

Outcomes

Primary Outcome Measures

Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.
Percentage of Participants Who Withdrew Due to Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Percentage of Participants With at Least One Serious Adverse Event (SAE)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Is as infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.

Secondary Outcome Measures

Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.
Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as: (the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines. Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of percent change in POS frequency.
Responder Rate in POS (Type I) Frequency Over the Evaluation Period
A responder is defined as a subject with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study. Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of responder rates in POS frequency.

Full Information

First Posted
April 19, 2011
Last Updated
August 16, 2021
Sponsor
UCB BIOSCIENCES, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01339559
Brief Title
Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
Acronym
BRITE™
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 11, 2011 (Actual)
Primary Completion Date
April 18, 2019 (Actual)
Study Completion Date
April 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Brivaracetam, Partial Onset Seizures, Adjunctive treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
767 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brivaracetam
Arm Type
Experimental
Arm Description
Brivaracetam with a maximum of 200 mg/day
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Other Intervention Name(s)
UCB34714
Intervention Description
Tablet, Flexible dosing up to 200 mg/day, twice daily. The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Description
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.
Time Frame
From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Title
Percentage of Participants Who Withdrew Due to Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Time Frame
From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Title
Percentage of Participants With at Least One Serious Adverse Event (SAE)
Description
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Is as infection that requires treatment parenteral antibiotics Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
Time Frame
From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Secondary Outcome Measure Information:
Title
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
Description
The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.
Time Frame
From Baseline of the previous study until the Last Visit (up to 84 months)
Title
Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
Description
The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as: (the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines. Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of percent change in POS frequency.
Time Frame
From Baseline of the previous study until the Last Visit (up to 84 months)
Title
Responder Rate in POS (Type I) Frequency Over the Evaluation Period
Description
A responder is defined as a subject with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study. Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of responder rates in POS frequency.
Time Frame
From Baseline of the previous study until the Last Visit (up to 84 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
001
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
013
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
006
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
775
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
025
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
060
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
071
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
027
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
064
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
023
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
048
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
039
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
029
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
005
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
017
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
020
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
069
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
780
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
008
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
068
City
Waldorf
State/Province
Maryland
ZIP/Postal Code
20603
Country
United States
Facility Name
009
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
032
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
042
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08619
Country
United States
Facility Name
099
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
022
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
098
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
010
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
003
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
034
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
778
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
070
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
002
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
043
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
091
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
054
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-83
Country
United States
Facility Name
015
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
028
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
021
City
Port Royal
State/Province
South Carolina
ZIP/Postal Code
29965
Country
United States
Facility Name
776
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-25
Country
United States
Facility Name
061
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
011
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
777
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
035
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
049
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
050
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76063
Country
United States
Facility Name
036
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
056
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
052
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
057
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
202
City
Innsbruck
Country
Austria
Facility Name
201
City
Linz
Country
Austria
Facility Name
203
City
Wien
Country
Austria
Facility Name
226
City
Hechtel-Eksel
Country
Belgium
Facility Name
227
City
Leuven
Country
Belgium
Facility Name
104
City
Belo Horizonte
Country
Brazil
Facility Name
100
City
Florianopolis
Country
Brazil
Facility Name
101
City
Sao Paulo
Country
Brazil
Facility Name
294
City
Blagoevgrad
Country
Bulgaria
Facility Name
286
City
Sofia
Country
Bulgaria
Facility Name
287
City
Sofia
Country
Bulgaria
Facility Name
075
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
078
City
London
State/Province
Ontario
Country
Canada
Facility Name
076
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
077
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
080
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
079
City
Montreal
Country
Canada
Facility Name
917
City
Brno
Country
Czechia
Facility Name
916
City
Kromeriz
Country
Czechia
Facility Name
913
City
Ostrava Poruba
Country
Czechia
Facility Name
251
City
Ostrava
Country
Czechia
Facility Name
256
City
Ostrava
Country
Czechia
Facility Name
252
City
Praha 1
Country
Czechia
Facility Name
253
City
Praha 4
Country
Czechia
Facility Name
250
City
Zlin
Country
Czechia
Facility Name
650
City
Tallinn
Country
Estonia
Facility Name
652
City
Tallinn
Country
Estonia
Facility Name
651
City
Tartu
Country
Estonia
Facility Name
275
City
Kuopio
Country
Finland
Facility Name
276
City
Tampere
Country
Finland
Facility Name
301
City
Bethune
Country
France
Facility Name
305
City
Montpellier
Country
France
Facility Name
329
City
Berlin
Country
Germany
Facility Name
326
City
Bernau
Country
Germany
Facility Name
332
City
Bielefeld
Country
Germany
Facility Name
902
City
Erlangen
Country
Germany
Facility Name
331
City
Göttingen
Country
Germany
Facility Name
327
City
Kiel
Country
Germany
Facility Name
900
City
Marburg
Country
Germany
Facility Name
335
City
Muenchen
Country
Germany
Facility Name
334
City
Osnabruck
Country
Germany
Facility Name
330
City
Ravensburg
Country
Germany
Facility Name
328
City
Ulm
Country
Germany
Facility Name
700
City
Hong Kong
Country
Hong Kong
Facility Name
701
City
Hong Kong
Country
Hong Kong
Facility Name
410
City
Budapest
Country
Hungary
Facility Name
411
City
Budapest
Country
Hungary
Facility Name
412
City
Budapest
Country
Hungary
Facility Name
414
City
Hajdú-Bihar
Country
Hungary
Facility Name
413
City
Szekszard
Country
Hungary
Facility Name
731
City
Nashik
State/Province
Maharashtra
Country
India
Facility Name
726
City
Bangalore
Country
India
Facility Name
727
City
Hyderabad
Country
India
Facility Name
729
City
Madurai
Country
India
Facility Name
725
City
Mumbai
Country
India
Facility Name
728
City
Mumbai
Country
India
Facility Name
378
City
Bari
Country
Italy
Facility Name
380
City
Firenze
Country
Italy
Facility Name
379
City
Milano
Country
Italy
Facility Name
377
City
Monserrato
Country
Italy
Facility Name
386
City
Napoli
Country
Italy
Facility Name
376
City
Perugia
Country
Italy
Facility Name
375
City
Pisa
Country
Italy
Facility Name
383
City
Pozzilli
Country
Italy
Facility Name
384
City
Reggio Calabria
Country
Italy
Facility Name
852
City
Itami
State/Province
Hyogo
Country
Japan
Facility Name
855
City
Hiroshima
Country
Japan
Facility Name
850
City
Osaka
Country
Japan
Facility Name
851
City
Shizuoka
Country
Japan
Facility Name
854
City
Yokohama-City
Country
Japan
Facility Name
753
City
Busan
Country
Korea, Republic of
Facility Name
750
City
Seoul
Country
Korea, Republic of
Facility Name
751
City
Seoul
Country
Korea, Republic of
Facility Name
754
City
Seoul
Country
Korea, Republic of
Facility Name
627
City
Daugavpils
Country
Latvia
Facility Name
629
City
Jekabpils
Country
Latvia
Facility Name
628
City
Riga
Country
Latvia
Facility Name
625
City
Valmiera
Country
Latvia
Facility Name
425
City
Alytus
Country
Lithuania
Facility Name
427
City
Kaunas
Country
Lithuania
Facility Name
426
City
Vilnius
Country
Lithuania
Facility Name
126
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
128
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
129
City
Aguascalientes
Country
Mexico
Facility Name
127
City
Culiacan
Country
Mexico
Facility Name
125
City
Distrito Federal
Country
Mexico
Facility Name
130
City
Mexico City
Country
Mexico
Facility Name
401
City
Heemstede
Country
Netherlands
Facility Name
400
City
Heeze
Country
Netherlands
Facility Name
403
City
Zwolle
Country
Netherlands
Facility Name
475
City
Bialystok
Country
Poland
Facility Name
485
City
Gdansk
Country
Poland
Facility Name
791
City
Gdansk
Country
Poland
Facility Name
478
City
Katowice
Country
Poland
Facility Name
480
City
Katowice
Country
Poland
Facility Name
481
City
Katowice
Country
Poland
Facility Name
795
City
Katowice
Country
Poland
Facility Name
476
City
Krakow
Country
Poland
Facility Name
793
City
Krakow
Country
Poland
Facility Name
483
City
Lublin
Country
Poland
Facility Name
477
City
Poznan
Country
Poland
Facility Name
479
City
Poznan
Country
Poland
Facility Name
482
City
Poznan
Country
Poland
Facility Name
488
City
Warszawa
Country
Poland
Facility Name
794
City
Warszawa
Country
Poland
Facility Name
038
City
San Juan
Country
Puerto Rico
Facility Name
501
City
Kazan
Country
Russian Federation
Facility Name
506
City
Kazan
Country
Russian Federation
Facility Name
502
City
Moscow
Country
Russian Federation
Facility Name
503
City
Moscow
Country
Russian Federation
Facility Name
509
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
508
City
Smolensk
Country
Russian Federation
Facility Name
528
City
Barcelona
Country
Spain
Facility Name
529
City
Barcelona
Country
Spain
Facility Name
535
City
Barcelona
Country
Spain
Facility Name
540
City
Barcelona
Country
Spain
Facility Name
539
City
San Sebastian
Country
Spain
Facility Name
532
City
Santiago de Compostela
Country
Spain
Facility Name
527
City
Valencia
Country
Spain
Facility Name
537
City
Valencia
Country
Spain
Facility Name
526
City
Valladolid
Country
Spain
Facility Name
551
City
Goteborg
Country
Sweden
Facility Name
552
City
Linkoping
Country
Sweden
Facility Name
550
City
Stockholm
Country
Sweden
Facility Name
806
City
Kaohsiung City
Country
Taiwan
Facility Name
801
City
Taichung
Country
Taiwan
Facility Name
800
City
Tainan
Country
Taiwan
Facility Name
803
City
Taoyuan
Country
Taiwan
Facility Name
602
City
Morriston
State/Province
Swansea
Country
United Kingdom
Facility Name
603
City
Birmingham
Country
United Kingdom
Facility Name
600
City
London
Country
United Kingdom
Facility Name
605
City
Middlesborough
Country
United Kingdom
Facility Name
607
City
Newcastle
Country
United Kingdom
Facility Name
608
City
Salford
Country
United Kingdom
Facility Name
601
City
Truro
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34218211
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.
Results Reference
result
PubMed Identifier
26899665
Citation
Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
Results Reference
derived
PubMed Identifier
26471380
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.
Results Reference
derived
Links:
URL
http://www.briviact.com/briviact-PI.pdf?v=1479491757
Description
Product Information
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy

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