Phase
Condition
Epilepsy
Treatment
Brivaracetam
Clinical Study ID
Ages > 1 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Inclusion criteria for long-term follow-up (LTFU) study participants only
- Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy whoparticipated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439]
Inclusion criteria for directly enrolled (DE) study participants in Japan only
Study participant is ≥ 4 years to < 16 years of age
Study participant has presence of an electroencephalogram (EEG) reading compatiblewith the diagnosis of focal epilepsy within the last 10 years
Study participant has uncontrolled partial-onset seizure (POS) after an adequatecourse of treatment with at least 1 antiepileptic drug (AED)
Study participant had at least 1 POS during the 4-week Screening Period
Exclusion
Exclusion Criteria:
Exclusion criteria for all study participants
Severe medical, neurological, or psychiatric disorders or laboratory values, whichmay have an impact on the safety of the study participant
Study participant is currently participating in another study of an investigationalmedication (or a medical device) other than brivaracetam (BRV).
Exclusion criteria for long-term follow-up (LTFU) study participants only
- Study participant ≥ 6 years of age has a lifetime history of suicide attempt or hassuicidal ideation in the past 6 months as indicated on the Columbia Suicide SeverityRating Scale (C-SSRS)
Exclusion criteria for directly enrolled (DE) study participants in Japan only
Study participant has a history of primary generalized epilepsy, psychogenicnon-epileptic seizures, or febrile seizures
Study participant has a history of status epilepticus in the 30 days prior to theScreening Visit (ScrV) or during the Screening Period
Study participant has any clinically significant illness
Study participant has clinically significant laboratory abnormality that mayincrease the risk associated with study participation or may interfere with theinterpretation of study results
Study participant has a clinically significant ECG abnormality
Study participant had major surgery within 6 months prior to the ScrV
Study Design
Study Description
Connect with a study center
Ep0156 204
Leuven,
BelgiumSite Not Available
Ep0156 240
Praha,
CzechiaSite Not Available
Ep0156 240
Praha 4,
CzechiaSite Not Available
Ep0156 207
Loos,
FranceSite Not Available
Ep0156 209
Freiburg,
GermanySite Not Available
Ep0156 210
Budapest,
HungaryCompleted
Ep0156 247
Budapest,
HungaryCompleted
Ep0156 232
Miskolc,
HungaryCompleted
Ep0156 230
Roma,
ItalyCompleted
Ep0156 803
Bunkyo-ku,
JapanSite Not Available
Ep0156 803
Bunkyō-Ku,
JapanSite Not Available
Ep0156 808
Chuo,
JapanSite Not Available
Ep0156 800
Gifu-City,
JapanSite Not Available
Ep0156 807
Hiroshima,
JapanSite Not Available
Ep0156 813
Kohshi,
JapanSite Not Available
Ep0156 813
Koshi,
JapanSite Not Available
Ep0156 806
Kyoto,
JapanSite Not Available
Ep0156 813
Kōshi,
JapanSite Not Available
Ep0156 811
Nagoya,
JapanSite Not Available
Ep0156 811
Nagoya city,
JapanSite Not Available
Ep0156 811
Nagoya-city,
JapanSite Not Available
Ep0156 812
Niigata,
JapanSite Not Available
Ep0156 812
Niigata city,
JapanSite Not Available
Ep0156 812
Niigata-city,
JapanSite Not Available
Ep0156 818
OBU,
JapanActive - Recruiting
Ep0156 819
Omura,
JapanActive - Recruiting
Ep0156 817
Osaka,
JapanActive - Recruiting
Ep0156 805
Sapporo,
JapanSite Not Available
Ep0156 805
Sapporo-city,
JapanSite Not Available
Ep0156 809
Shimots UKE,
JapanSite Not Available
Ep0156 809
Shimotsuke,
JapanSite Not Available
Ep0156 814
Shizuoka,
JapanActive - Recruiting
Ep0156 804
Tokyo,
JapanSite Not Available
Ep0156 810
Yokohama,
JapanSite Not Available
Ep0156 802
Yonago,
JapanCompleted
Ep0156 223
Aguascalientes,
MexicoCompleted
Ep0156 611
Chihuahua,
MexicoSite Not Available
Ep0156 609
Culiacan,
MexicoCompleted
Ep0156 609
Culiacán,
MexicoSite Not Available
Ep0156 603
Guadala JARA,
MexicoSite Not Available
Ep0156 603
Guadalajara,
MexicoCompleted
Ep0156 406
Kielce,
PolandCompleted
Ep0156 402
Krakow,
PolandCompleted
Ep0156 402
Kraków,
PolandSite Not Available
Ep0156 401
Poznan,
PolandCompleted
Ep0156 401
Poznań,
PolandSite Not Available
Ep0156 248
Sevilla,
SpainCompleted
Ep0156 259
Hawthorne, New York 10532
United StatesCompleted
Ep0156 259
Sleepy Hollow, New York 10591
United StatesSite Not Available
Ep0156 237
Durham, North Carolina 27710
United StatesCompleted


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