Phase
Condition
Epilepsy
Seizure Disorders
Treatment
Brivaracetam oral solution
Brivaracetam Film-coated tablet
Clinical Study ID
Ages 2-26 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who previously participated in N01269 (NCT04666610) and qualify forentry into EP0132 as per N01269 (NCT04666610) protocol with a confirmed diagnosis ofchildhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE), and for whom areasonable benefit from long-term administration of brivaracetam (BRV) is expected,in the opinion of the Investigator
A sexually active male study participant must agree to use contraception during thetreatment period and for at least 2 days, corresponding to the time needed toeliminate study treatment, after the last dose of study treatment and refrain fromdonating sperm during this period
A female study participant is eligible to participate if she is not pregnant, notbreastfeeding, and at least 1 of the following conditions applies:
The study participant is premenarchal OR
A woman of childbearing potential (WOCBP) who agrees to follow thecontraceptive guidance during the treatment period and for at least 2 daysafter the last dose of study medication, corresponding to the time needed toeliminate study treatment
- Study participant is capable of and provides consent/assent, and the studyparticipant's parent/legal representative/caregiver provides signed informed consentfor minor study participants, which includes compliance with the requirements andrestrictions listed in the informed consent form (ICF) and in this protocol
Exclusion
Exclusion Criteria:
Study participant has a history or presence of paroxysmal nonepileptic seizures
Study participant has severe medical, neurological, or psychiatric disorders orlaboratory values, which could, at the discretion of the Investigator, affect safeparticipation in the study or would preclude appropriate study participation
Study participant has a clinically relevant electrocardiogram (ECG) abnormality inthe opinion of the Principal Investigator
Study participant has hepatic impairment (Child Pugh Score A, B, or C) based on theInvestigator's assessment
Study participant has active suicidal ideation prior to study entry as indicated bya positive response ("Yes") to either Question 4 or Question 5 of the ColumbiaSuicide Severity Rating Scale (C-SSRS) (for study participants 6 years or older) orclinical judgment (for study participants younger than 6 years). The studyparticipant should be referred immediately to a Mental Healthcare Professional
Study participant has a lifetime history of suicide attempt (including an activeattempt, interrupted attempt, or aborted attempt). The Investigator must immediatelyrefer the study participant to a Mental Healthcare Professional
Participant has any medical or psychiatric condition that, in the opinion of theInvestigator, could jeopardize or would compromise the study participant's abilityto participate in this study
Participant has a known fructose intolerance or known hypersensitivity to anycomponents of brivaracetam (BRV) or excipients or a drug with similar chemicalstructure. Note that the tablets contain lactose
Study participant has end-stage kidney disease requiring dialysis
Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine,phenobarbital, phenytoin, tiagabine, or vigabatrin
Study participant has planned participation in any clinical study on aninvestigational drug or device
Study participant has poor compliance with the visit schedule or medication intakein the core study in the opinion of the Investigator
Study Design
Connect with a study center
Ep0132 400
Tbilisi,
GeorgiaSite Not Available
Ep0132 401
Tbilisi,
GeorgiaSite Not Available
Ep0132 402
Tbilisi,
GeorgiaSite Not Available
Ep0132 403
Tbilisi,
GeorgiaSite Not Available
Ep0132 405
Tbilisi,
GeorgiaSite Not Available
Ep0132 323
Messina,
ItalySite Not Available
Ep0132 321
Milano,
ItalySite Not Available
Ep0132 324
Milano,
ItalySite Not Available
Ep0132 320
Pavia,
ItalySite Not Available
Ep0132 322
Roma,
ItalySite Not Available
Ep0132 325
Roma,
ItalySite Not Available
Ep0132 326
Verona,
ItalySite Not Available
Ep0132 562
Bucuresti,
RomaniaSite Not Available
Ep0132 563
Bucuresti,
RomaniaSite Not Available
Ep0132 560
Iasi,
RomaniaSite Not Available
Ep0132 561
Timişoara, Judeţ Timiş,
RomaniaSite Not Available
Ep0132 632
Bardejov,
SlovakiaSite Not Available
Ep0132 630
Dubnica Nad Vahom,
SlovakiaSite Not Available
Ep0132 354
Terrassa,
SpainSite Not Available
Ep0132 600
Dnipro,
UkraineSite Not Available
Ep0132 601
Dnipro,
UkraineSite Not Available
Ep0132 607
Uzhgorod,
UkraineSite Not Available
Ep0132 602
Vinnytsia,
UkraineSite Not Available
Ep0132 607
Úzhgorod,
UkraineSite Not Available
Ep0132 115
Birmingham, Alabama 35233
United StatesSite Not Available
Ep0132 105
Orange, California 92868-3874
United StatesSite Not Available
Ep0132 116
Denver, Colorado 80202
United StatesSite Not Available
Ep0132 110
Augusta, Georgia 30912
United StatesSite Not Available
Ep0132 100
New Brunswick, New Jersey 08901
United StatesSite Not Available
Ep0132 109
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Ep0132 106
Philadelphia, Pennsylvania 19134
United StatesSite Not Available
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