Phase
Condition
Seizure Disorders
Epilepsy
Treatment
Brivaracetam oral solution
Brivaracetam Film-coated tablet
Clinical Study ID
Ages > 2 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who previously participated in EP0132 (NCT05109234) and/or N01269 (NCT04666610) and qualify for entry into EP0224 as per the EP0132 or N01269 protocolwith a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absenceepilepsy (JAE)
Participants for whom a reasonable benefit from long-term administration ofBrivaracetam (BRV) is expected in the opinion of the Investigator
Male and female A male participant must agree to use contraception during thetreatment period and for at least 2 days after the final dose of investigationalmedicinal product (IMP) and refrain from donating sperm during this period.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the final dose of IMP.
- Capable of and provides informed consent/assent, and the participant's parent/legalrepresentative/caregiver provides signed informed consent for minor participants,which includes compliance with the requirements and restrictions listed in theInformed Consent form (ICF)/Assent form and in this protocol
Exclusion
Exclusion Criteria:
Participant has a history or presence of paroxysmal nonepileptic seizures
Participant has severe medical, neurological, or psychiatric disorders or laboratoryvalues which could, at the discretion of the Investigator, affect safe participationin the study or would preclude appropriate study participation
Participant has hepatic impairment (Child Pugh Score A, B, or C) based on theInvestigator's assessment
Participant has active suicidal ideation prior to study entry as indicated by apositive response ("Yes") to either Question 4 or Question 5 of the Columbia-SuicideSeverity Rating Scale (C-SSRS) (for participants 6 years of age or older) orclinical judgment (for participants younger than 6 years of age). The participantshould be referred immediately to a Mental Healthcare Professional
Participant has any medical or psychiatric condition that, in the opinion of theInvestigator, could jeopardize or would compromise the participant's ability toparticipate in this study
Participant has known fructose intolerance or a known hypersensitivity to anycomponents of BRV or excipients or a drug with similar chemical structure
Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine,phenobarbital, phenytoin, tiagabine, or vigabatrin
Participant is receiving any investigational drugs or using any experimental devicesin addition to BRV
Participant meets a mandatory withdrawal criterion for N01269 or EP0132 or isexperiencing an ongoing Serious adverse event (SAE)
Participant has poor compliance with the visit schedule or IMP intake in thepreceding study in the opinion of the Investigator
Study Design
Connect with a study center
Ep0224 20321
Tbilisi,
GeorgiaActive - Recruiting
Ep0224 20322
Tbilisi,
GeorgiaActive - Recruiting
Ep0224 20323
Tbilisi,
GeorgiaActive - Recruiting
Ep0224 20324
Tbilisi,
GeorgiaActive - Recruiting
Ep0224 40765
Messina,
ItalyActive - Recruiting
Ep0224 40144
Milano,
ItalyActive - Recruiting
Ep0224 40764
Pavia,
ItalyActive - Recruiting
Ep0224 40629
Roma,
ItalyActive - Recruiting
Ep0224 40763
Verona,
ItalyActive - Recruiting
Ep0224 40767
Bucharest,
RomaniaActive - Recruiting
Ep0224 40769
Bucuresti,
RomaniaActive - Recruiting
Ep0224 40768
Iasi,
RomaniaActive - Recruiting
Ep0224 40770
Timisoara,
RomaniaActive - Recruiting
Ep0224 40771
Bardejov,
SlovakiaActive - Recruiting
Ep0224 40772
Dubnica Nad Vahom,
SlovakiaActive - Recruiting
Ep0224 40453
Terrassa,
SpainActive - Recruiting
Ep0224 20328
Uzhgorod,
UkraineActive - Recruiting
Ep0224 50140
Birmingham, Alabama 35233
United StatesActive - Recruiting
Ep0224 50639
Orange, California 92868
United StatesActive - Recruiting
Ep0224 50268
Miami, Florida 33155
United StatesActive - Recruiting
Ep0224 50544
Augusta, Georgia 30912
United StatesSite Not Available
Ep0224 50638
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Ep0224 50640
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.