Phase
Condition
Epilepsy
Seizure Disorders
Treatment
Placebo
Brivaracetam
Clinical Study ID
Ages 2-25 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Study participant is 2 to 25 years of age inclusive, at the time of signing theinformed consent. No study participants from 2 to <4 years of age will be includedin Stage 1
Study participant is diagnosed with either childhood absence epilepsy (CAE) orjuvenile absence epilepsy (JAE) as defined by the International League AgainstEpilepsy (ILAE) criteria
Study participants 2 to <4 years of age and participants who had onset of absenceseizures at an age younger than 4 years must have a negative glucose transportertype 1 deficiency syndrome (GLUT1DS) genetic test
Study participant is untreated with antiepileptic drugs (AEDs) or pretreated forabsence seizures with a maximum of 2 historical AEDs, but without AED treatment fora period of at least 5 half-lives of the AED before randomization into this study.The UCB study physician should be consulted if in doubt
Study participant has electroencephalogram (EEG) evidence of bilateral synchronous,symmetric generalized paroxysmal spike waves (2.5-6 hertz) with normal backgroundactivity and with at least 1 electrographically recorded seizure lasting 3 secondsor more on a 1-hour EEG with hyperventilation (HV) while awake at Visit 1 (V1), oron a historical EEG up to 12 weeks before enrollment
Study participant has a history of clinically evident absence seizures occurring onat least 3 days per week in the 2 weeks prior to enrollment
Study participant is without treatment with psychoactive drugs or on a stable dosefor at least 2 weeks prior to randomization
Study participant has normal neurological examination, head size, development andcognition
Body weight is ≥9 kg
Male and female a) A sexually active male study participant must agree to use contraception duringthe treatment 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 b) A female study participant is eligible toparticipate if she is not pregnant, not breastfeeding, and at least 1 of thefollowing conditions applies: The study participant is premenarchial OR A woman ofchildbearing potential (WOCBP) who agrees to follow the contraceptive guidanceduring the treatment period and for at least 2 days after the last dose of studytreatment, corresponding to the time needed to eliminate study treatment
Study participant provides consent/assent, and the study participant's parent/legalrepresentative/caregiver provides signed informed consent for minor studyparticipants, which includes compliance with the requirements and restrictionslisted in the informed consent form (ICF) and in this protocol
Exclusion
Exclusion Criteria:
Study participant has a history of nonfebrile seizures other than absence seizures (eg, generalized tonic-clonic seizures or myoclonic seizures)
Study participant has a history of absence status epilepticus
Study participant has a history or presence of paroxysmal nonepileptic seizures
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 a history of major psychiatric disease or any clinicallysignificant medical condition that would preclude appropriate study participation
Study participant has active suicidal ideation prior to study entry as indicated bya positive response ("Yes") to either Question 4 or Question 5 of theColumbia-Suicide Severity Rating Scale (C-SSRS; for study participants 6 years orolder) or clinical judgement (for study participants younger than 6 years). Thestudy participant 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 study participant should beimmediately evaluated by a Mental Healthcare Professional to address safety concerns
Study participant with known fructose intolerance or hypersensitivity of any of theingredients in brivaracetam oral solution
Study participant has end-stage kidney disease requiring dialysis
Concomitant use of rifampicin/rifampin; prior use must have been stopped at least 2months before randomization
Concomitant use of strong CYP2C19 inhibitors like fluconazole, fluoxetine andfluvoxamine, prior use must have been stopped at least 1 week before randomization
Study participant has participated in another study of an investigational medicinalproduct (IMP; and/or an investigational device) within the previous 30 days prior toinformed consent
Study participant has clinical or EEG findings not consistent with a diagnosis ofchildhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)
Study Design
Connect with a study center
N01269 203
Heidelberg,
AustraliaSite Not Available
N01269 202
Melbourne,
AustraliaSite Not Available
N01269 200
Randwick,
AustraliaSite Not Available
N01269 201
South Brisbane,
AustraliaSite Not Available
N01269 301
Bruxelles,
BelgiumSite Not Available
N01269 300
Edegem,
BelgiumSite Not Available
N01269 400
Tbilisi,
GeorgiaActive - Recruiting
N01269 401
Tbilisi,
GeorgiaActive - Recruiting
N01269 402
Tbilisi,
GeorgiaCompleted
N01269 403
Tbilisi,
GeorgiaActive - Recruiting
N01269 405
Tbilisi,
GeorgiaActive - Recruiting
N01269 323
Messina,
ItalyActive - Recruiting
N01269 321
Milano,
ItalyActive - Recruiting
N01269 324
Milano,
ItalyActive - Recruiting
N01269 320
Pavia,
ItalyActive - Recruiting
N01269 322
Roma,
ItalyActive - Recruiting
N01269 325
Roma,
ItalyActive - Recruiting
N01269 326
Verona,
ItalyActive - Recruiting
N01269 533
Gdansk,
PolandSite Not Available
N01269 533
Gdańsk,
PolandSite Not Available
N01269 530
Krakow,
PolandSite Not Available
N01269 530
Kraków,
PolandSite Not Available
N01269 534
Lodz,
PolandSite Not Available
N01269 531
Lublin,
PolandSite Not Available
N01269 532
Warszawa,
PolandSite Not Available
N01269 534
Łódź,
PolandSite Not Available
N01269 562
Bucuresti,
RomaniaActive - Recruiting
N01269 563
Bucuresti,
RomaniaActive - Recruiting
N01269 560
Iasi,
RomaniaActive - Recruiting
N01269 560
Iaşi,
RomaniaSite Not Available
N01269 561
Timişoara,
RomaniaSite Not Available
N01269 561
Timişoara, Judeţ Timiş,
RomaniaActive - Recruiting
N01269 632
Bardejov,
SlovakiaActive - Recruiting
N01269 630
Dubnica Nad Vahom,
SlovakiaActive - Recruiting
N01269 631
Nove Zamky,
SlovakiaCompleted
N01269 351
Madrid,
SpainSite Not Available
N01269 353
Sevilla,
SpainSite Not Available
N01269 354
Terrassa,
SpainActive - Recruiting
N01269 600
Dnipro,
UkraineCompleted
N01269 601
Dnipro,
UkraineSite Not Available
N01269 604
Kharkiv,
UkraineCompleted
N01269 608
Kharkiv,
UkraineSite Not Available
N01269 603
Kyiv,
UkraineSite Not Available
N01269 606
Kyiv,
UkraineSite Not Available
N01269 607
Uzhgorod,
UkraineCompleted
N01269 602
Vinnytsia,
UkraineCompleted
N01269 607
Úzhgorod,
UkraineSite Not Available
N01269 115
Birmingham, Alabama 35233
United StatesActive - Recruiting
N01269 118
Long Beach, California 90806
United StatesSite Not Available
N01269 105
Orange, California 92868-3874
United StatesActive - Recruiting
N01269 116
Denver, Colorado 80202
United StatesCompleted
N01269 103
Loxahatchee Groves, Florida 33470
United StatesSite Not Available
N01269 111
Miami, Florida 33155-3009
United StatesActive - Recruiting
N01269 104
Orlando, Florida 32819
United StatesActive - Recruiting
N01269 Site 104
Orlando, Florida 32819
United StatesSite Not Available
N01269 101
Tampa, Florida 33612
United StatesCompleted
N01269 Site 103
Wellington, Florida 33414
United StatesSite Not Available
N01269 104
Winter Park, Florida 32789
United StatesCompleted
N01269 110
Augusta, Georgia 30912
United StatesCompleted
N01269 100
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
N01269 109
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
N01269 106
Philadelphia, Pennsylvania 19134
United StatesCompleted
N01269 Site 106
Philadelphia, Pennsylvania 19134
United StatesSite Not Available
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