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 more than or equal to 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 203
Heidelberg 2163654,
AustraliaSite Not Available
N01269 203
Heidelberg Heights 9972412,
AustraliaSite Not Available
N01269 202
Melbourne,
AustraliaSite Not Available
N01269 202
Melbourne 2158177,
AustraliaSite Not Available
N01269 200
Randwick,
AustraliaSite Not Available
N01269 200
Randwick 2208285,
AustraliaSite Not Available
N01269 201
South Brisbane,
AustraliaSite Not Available
N01269 201
South Brisbane 2207259,
AustraliaSite Not Available
N01269 301
Brussels 2800866,
BelgiumSite Not Available
N01269 301
Bruxelles,
BelgiumSite Not Available
N01269 300
Edegem,
BelgiumSite Not Available
N01269 300
Edegem 2799007,
BelgiumSite Not Available
N01269 400
Tbilisi,
GeorgiaSite Not Available
N01269 401
Tbilisi,
GeorgiaSite Not Available
N01269 402
Tbilisi,
GeorgiaSite Not Available
N01269 403
Tbilisi,
GeorgiaSite Not Available
N01269 405
Tbilisi,
GeorgiaSite Not Available
N01269 400
Tbilisi 611717,
GeorgiaActive - Recruiting
N01269 401
Tbilisi 611717,
GeorgiaSite Not Available
N01269 402
Tbilisi 611717,
GeorgiaCompleted
N01269 403
Tbilisi 611717,
GeorgiaActive - Recruiting
N01269 405
Tbilisi 611717,
GeorgiaActive - Recruiting
N01269 323
Messina,
ItalySite Not Available
N01269 323
Messina 2524170,
ItalySite Not Available
N01269 321
Milan,
ItalySite Not Available
N01269 324
Milan,
ItalySite Not Available
N01269 321
Milan 6951411,
ItalyActive - Recruiting
N01269 324
Milan 6951411,
ItalySite Not Available
N01269 321
Milano,
ItalySite Not Available
N01269 324
Milano,
ItalyActive - Recruiting
N01269 320
Pavia,
ItalySite Not Available
N01269 320
Pavia 3171366,
ItalySite Not Available
N01269 322
Roma,
ItalySite Not Available
N01269 325
Roma,
ItalySite Not Available
N01269 322
Roma 8957247,
ItalySite Not Available
N01269 325
Roma 8957247,
ItalyActive - Recruiting
N01269 326
Verona,
ItalySite Not Available
N01269 326
Verona 3164527,
ItalySite Not Available
N01269 533
Gdansk,
PolandSite Not Available
N01269 533
Gdansk 3099434,
PolandSite Not Available
N01269 533
Gdańsk,
PolandSite Not Available
N01269 530
Krakow,
PolandSite Not Available
N01269 530
Krakow 3094802,
PolandSite Not Available
N01269 530
Kraków,
PolandSite Not Available
N01269 534
Lodz,
PolandSite Not Available
N01269 534
Lodz 3093133,
PolandSite Not Available
N01269 531
Lublin,
PolandSite Not Available
N01269 531
Lublin 765876,
PolandSite Not Available
N01269 532
Warsaw 756135,
PolandSite Not Available
N01269 532
Warszawa,
PolandSite Not Available
N01269 534
Łódź,
PolandSite Not Available
N01269 562
Bucharest,
RomaniaSite Not Available
N01269 563
Bucharest,
RomaniaSite Not Available
N01269 562
Bucharest 683506,
RomaniaSite Not Available
N01269 563
Bucharest 683506,
RomaniaActive - Recruiting
N01269 562
Bucuresti,
RomaniaSite Not Available
N01269 563
Bucuresti,
RomaniaActive - Recruiting
N01269 560
Iasi,
RomaniaSite Not Available
N01269 560
Iaşi,
RomaniaSite Not Available
N01269 560
Iași,
RomaniaSite Not Available
N01269 560
Iași 675810,
RomaniaSite Not Available
N01269 561
Timişoara,
RomaniaSite Not Available
N01269 561
Timişoara, Judeţ Timiş,
RomaniaSite Not Available
N01269 561
Timişoara, Judeţ Timiş 665087,
RomaniaSite Not Available
N01269 632
Bardejov,
SlovakiaSite Not Available
N01269 632
Bardejov 725168,
SlovakiaSite Not Available
N01269 630
Dubnica Nad Vahom,
SlovakiaSite Not Available
N01269 630
Dubnica nad Váhom,
SlovakiaSite Not Available
N01269 630
Dubnica nad Váhom 3060346,
SlovakiaSite Not Available
N01269 631
Nove Zamky,
SlovakiaSite Not Available
N01269 631
Nové Zámky,
SlovakiaSite Not Available
N01269 631
Nové Zámky 3058472,
SlovakiaSite Not Available
N01269 351
Madrid,
SpainSite Not Available
N01269 351
Madrid 3117735,
SpainSite Not Available
N01269 353
Sevilla,
SpainSite Not Available
N01269 353
Seville 2510911,
SpainSite Not Available
N01269 354
Terrassa,
SpainSite Not Available
N01269 354
Terrassa 3108286,
SpainSite Not Available
N01269 600
Dnipro,
UkraineSite Not Available
N01269 601
Dnipro,
UkraineSite Not Available
N01269 600
Dnipro 709930,
UkraineSite Not Available
N01269 601
Dnipro 709930,
UkraineCompleted
N01269 604
Kharkiv,
UkraineSite Not Available
N01269 608
Kharkiv,
UkraineSite Not Available
N01269 604
Kharkiv 706483,
UkraineSite Not Available
N01269 608
Kharkiv 706483,
UkraineSite Not Available
N01269 603
Kyiv,
UkraineSite Not Available
N01269 606
Kyiv,
UkraineSite Not Available
N01269 603
Kyiv 703448,
UkraineSite Not Available
N01269 606
Kyiv 703448,
UkraineSite Not Available
N01269 607
Uzhgorod,
UkraineSite Not Available
N01269 607
Uzhhorod,
UkraineSite Not Available
N01269 607
Uzhhorod 690548,
UkraineSite Not Available
N01269 602
Vinnytsia,
UkraineSite Not Available
N01269 602
Vinnytsia 689558,
UkraineSite Not Available
N01269 607
Úzhgorod,
UkraineSite Not Available
N01269 115
Birmingham, Alabama 35233
United StatesSite Not Available
N01269 115
Birmingham 4049979, Alabama 4829764 35233
United StatesSite Not Available
N01269 118
Long Beach, California 90806
United StatesSite Not Available
N01269 105
Orange, California 92868-3874
United StatesSite Not Available
N01269 118
Long Beach 5367929, California 5332921 90806
United StatesSite Not Available
N01269 105
Orange 5379513, California 5332921 92868-3874
United StatesSite Not Available
N01269 116
Denver, Colorado 80202
United StatesSite Not Available
N01269 116
Denver 5419384, Colorado 5417618 80202
United StatesSite Not Available
N01269 103
Loxahatchee Groves, Florida 33470
United StatesSite Not Available
N01269 111
Miami, Florida 33155-3009
United StatesSite Not Available
N01269 104
Orlando, Florida 32819
United StatesActive - Recruiting
N01269 Site 104
Orlando, Florida 32819
United StatesSite Not Available
N01269 101
Tampa, Florida 33612
United StatesSite Not Available
N01269 Site 103
Wellington, Florida 33414
United StatesSite Not Available
N01269 104
Winter Park, Florida 32789
United StatesSite Not Available
N01269 103
Loxahatchee Groves 4162948, Florida 4155751 33470
United StatesSite Not Available
N01269 111
Miami 4164138, Florida 4155751 33155-3009
United StatesSite Not Available
N01269 101
Tampa 4174757, Florida 4155751 33612
United StatesSite Not Available
N01269 104
Winter Park 4178560, Florida 4155751 32789
United StatesSite Not Available
N01269 110
Augusta, Georgia 30912
United StatesSite Not Available
N01269 110
Augusta 4180531, Georgia 4197000 30912
United StatesSite Not Available
N01269 100
New Brunswick, New Jersey 08901
United StatesSite Not Available
N01269 100
New Brunswick 5101717, New Jersey 5101760 08901
United StatesSite Not Available
N01269 109
Winston-Salem, North Carolina 27109
United StatesSite Not Available
N01269 109
Winston-Salem 4499612, North Carolina 4482348 27109
United StatesSite Not Available
N01269 106
Philadelphia, Pennsylvania 19134
United StatesSite Not Available
N01269 Site 106
Philadelphia, Pennsylvania 19134
United StatesSite Not Available
N01269 106
Philadelphia 4560349, Pennsylvania 6254927 19134
United StatesSite Not Available

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.