A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Last updated: March 12, 2026
Sponsor: UCB Biopharma SRL
Overall Status: Active - Not Recruiting

Phase

3

Condition

Epilepsy

Seizure Disorders

Treatment

Placebo

Brivaracetam

Clinical Study ID

NCT04666610
N01269
U1111-1303-2521
2020-002750-24
2023-510428-55-00
  • Ages 2-25
  • All Genders

Study Summary

The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).

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

Total Participants: 153
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
July 29, 2021
Estimated Completion Date:
August 24, 2026

Connect with a study center

  • N01269 203

    Heidelberg,
    Australia

    Site Not Available

  • N01269 203

    Heidelberg 2163654,
    Australia

    Site Not Available

  • N01269 203

    Heidelberg Heights 9972412,
    Australia

    Site Not Available

  • N01269 202

    Melbourne,
    Australia

    Site Not Available

  • N01269 202

    Melbourne 2158177,
    Australia

    Site Not Available

  • N01269 200

    Randwick,
    Australia

    Site Not Available

  • N01269 200

    Randwick 2208285,
    Australia

    Site Not Available

  • N01269 201

    South Brisbane,
    Australia

    Site Not Available

  • N01269 201

    South Brisbane 2207259,
    Australia

    Site Not Available

  • N01269 301

    Brussels 2800866,
    Belgium

    Site Not Available

  • N01269 301

    Bruxelles,
    Belgium

    Site Not Available

  • N01269 300

    Edegem,
    Belgium

    Site Not Available

  • N01269 300

    Edegem 2799007,
    Belgium

    Site Not Available

  • N01269 400

    Tbilisi,
    Georgia

    Site Not Available

  • N01269 401

    Tbilisi,
    Georgia

    Site Not Available

  • N01269 402

    Tbilisi,
    Georgia

    Site Not Available

  • N01269 403

    Tbilisi,
    Georgia

    Site Not Available

  • N01269 405

    Tbilisi,
    Georgia

    Site Not Available

  • N01269 400

    Tbilisi 611717,
    Georgia

    Active - Recruiting

  • N01269 401

    Tbilisi 611717,
    Georgia

    Site Not Available

  • N01269 402

    Tbilisi 611717,
    Georgia

    Completed

  • N01269 403

    Tbilisi 611717,
    Georgia

    Active - Recruiting

  • N01269 405

    Tbilisi 611717,
    Georgia

    Active - Recruiting

  • N01269 323

    Messina,
    Italy

    Site Not Available

  • N01269 323

    Messina 2524170,
    Italy

    Site Not Available

  • N01269 321

    Milan,
    Italy

    Site Not Available

  • N01269 324

    Milan,
    Italy

    Site Not Available

  • N01269 321

    Milan 6951411,
    Italy

    Active - Recruiting

  • N01269 324

    Milan 6951411,
    Italy

    Site Not Available

  • N01269 321

    Milano,
    Italy

    Site Not Available

  • N01269 324

    Milano,
    Italy

    Active - Recruiting

  • N01269 320

    Pavia,
    Italy

    Site Not Available

  • N01269 320

    Pavia 3171366,
    Italy

    Site Not Available

  • N01269 322

    Roma,
    Italy

    Site Not Available

  • N01269 325

    Roma,
    Italy

    Site Not Available

  • N01269 322

    Roma 8957247,
    Italy

    Site Not Available

  • N01269 325

    Roma 8957247,
    Italy

    Active - Recruiting

  • N01269 326

    Verona,
    Italy

    Site Not Available

  • N01269 326

    Verona 3164527,
    Italy

    Site Not Available

  • N01269 533

    Gdansk,
    Poland

    Site Not Available

  • N01269 533

    Gdansk 3099434,
    Poland

    Site Not Available

  • N01269 533

    Gdańsk,
    Poland

    Site Not Available

  • N01269 530

    Krakow,
    Poland

    Site Not Available

  • N01269 530

    Krakow 3094802,
    Poland

    Site Not Available

  • N01269 530

    Kraków,
    Poland

    Site Not Available

  • N01269 534

    Lodz,
    Poland

    Site Not Available

  • N01269 534

    Lodz 3093133,
    Poland

    Site Not Available

  • N01269 531

    Lublin,
    Poland

    Site Not Available

  • N01269 531

    Lublin 765876,
    Poland

    Site Not Available

  • N01269 532

    Warsaw 756135,
    Poland

    Site Not Available

  • N01269 532

    Warszawa,
    Poland

    Site Not Available

  • N01269 534

    Łódź,
    Poland

    Site Not Available

  • N01269 562

    Bucharest,
    Romania

    Site Not Available

  • N01269 563

    Bucharest,
    Romania

    Site Not Available

  • N01269 562

    Bucharest 683506,
    Romania

    Site Not Available

  • N01269 563

    Bucharest 683506,
    Romania

    Active - Recruiting

  • N01269 562

    Bucuresti,
    Romania

    Site Not Available

  • N01269 563

    Bucuresti,
    Romania

    Active - Recruiting

  • N01269 560

    Iasi,
    Romania

    Site Not Available

  • N01269 560

    Iaşi,
    Romania

    Site Not Available

  • N01269 560

    Iași,
    Romania

    Site Not Available

  • N01269 560

    Iași 675810,
    Romania

    Site Not Available

  • N01269 561

    Timişoara,
    Romania

    Site Not Available

  • N01269 561

    Timişoara, Judeţ Timiş,
    Romania

    Site Not Available

  • N01269 561

    Timişoara, Judeţ Timiş 665087,
    Romania

    Site Not Available

  • N01269 632

    Bardejov,
    Slovakia

    Site Not Available

  • N01269 632

    Bardejov 725168,
    Slovakia

    Site Not Available

  • N01269 630

    Dubnica Nad Vahom,
    Slovakia

    Site Not Available

  • N01269 630

    Dubnica nad Váhom,
    Slovakia

    Site Not Available

  • N01269 630

    Dubnica nad Váhom 3060346,
    Slovakia

    Site Not Available

  • N01269 631

    Nove Zamky,
    Slovakia

    Site Not Available

  • N01269 631

    Nové Zámky,
    Slovakia

    Site Not Available

  • N01269 631

    Nové Zámky 3058472,
    Slovakia

    Site Not Available

  • N01269 351

    Madrid,
    Spain

    Site Not Available

  • N01269 351

    Madrid 3117735,
    Spain

    Site Not Available

  • N01269 353

    Sevilla,
    Spain

    Site Not Available

  • N01269 353

    Seville 2510911,
    Spain

    Site Not Available

  • N01269 354

    Terrassa,
    Spain

    Site Not Available

  • N01269 354

    Terrassa 3108286,
    Spain

    Site Not Available

  • N01269 600

    Dnipro,
    Ukraine

    Site Not Available

  • N01269 601

    Dnipro,
    Ukraine

    Site Not Available

  • N01269 600

    Dnipro 709930,
    Ukraine

    Site Not Available

  • N01269 601

    Dnipro 709930,
    Ukraine

    Completed

  • N01269 604

    Kharkiv,
    Ukraine

    Site Not Available

  • N01269 608

    Kharkiv,
    Ukraine

    Site Not Available

  • N01269 604

    Kharkiv 706483,
    Ukraine

    Site Not Available

  • N01269 608

    Kharkiv 706483,
    Ukraine

    Site Not Available

  • N01269 603

    Kyiv,
    Ukraine

    Site Not Available

  • N01269 606

    Kyiv,
    Ukraine

    Site Not Available

  • N01269 603

    Kyiv 703448,
    Ukraine

    Site Not Available

  • N01269 606

    Kyiv 703448,
    Ukraine

    Site Not Available

  • N01269 607

    Uzhgorod,
    Ukraine

    Site Not Available

  • N01269 607

    Uzhhorod,
    Ukraine

    Site Not Available

  • N01269 607

    Uzhhorod 690548,
    Ukraine

    Site Not Available

  • N01269 602

    Vinnytsia,
    Ukraine

    Site Not Available

  • N01269 602

    Vinnytsia 689558,
    Ukraine

    Site Not Available

  • N01269 607

    Úzhgorod,
    Ukraine

    Site Not Available

  • N01269 115

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • N01269 115

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • N01269 118

    Long Beach, California 90806
    United States

    Site Not Available

  • N01269 105

    Orange, California 92868-3874
    United States

    Site Not Available

  • N01269 118

    Long Beach 5367929, California 5332921 90806
    United States

    Site Not Available

  • N01269 105

    Orange 5379513, California 5332921 92868-3874
    United States

    Site Not Available

  • N01269 116

    Denver, Colorado 80202
    United States

    Site Not Available

  • N01269 116

    Denver 5419384, Colorado 5417618 80202
    United States

    Site Not Available

  • N01269 103

    Loxahatchee Groves, Florida 33470
    United States

    Site Not Available

  • N01269 111

    Miami, Florida 33155-3009
    United States

    Site Not Available

  • N01269 104

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • N01269 Site 104

    Orlando, Florida 32819
    United States

    Site Not Available

  • N01269 101

    Tampa, Florida 33612
    United States

    Site Not Available

  • N01269 Site 103

    Wellington, Florida 33414
    United States

    Site Not Available

  • N01269 104

    Winter Park, Florida 32789
    United States

    Site Not Available

  • N01269 103

    Loxahatchee Groves 4162948, Florida 4155751 33470
    United States

    Site Not Available

  • N01269 111

    Miami 4164138, Florida 4155751 33155-3009
    United States

    Site Not Available

  • N01269 101

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • N01269 104

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • N01269 110

    Augusta, Georgia 30912
    United States

    Site Not Available

  • N01269 110

    Augusta 4180531, Georgia 4197000 30912
    United States

    Site Not Available

  • N01269 100

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • N01269 100

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Site Not Available

  • N01269 109

    Winston-Salem, North Carolina 27109
    United States

    Site Not Available

  • N01269 109

    Winston-Salem 4499612, North Carolina 4482348 27109
    United States

    Site Not Available

  • N01269 106

    Philadelphia, Pennsylvania 19134
    United States

    Site Not Available

  • N01269 Site 106

    Philadelphia, Pennsylvania 19134
    United States

    Site Not Available

  • N01269 106

    Philadelphia 4560349, Pennsylvania 6254927 19134
    United States

    Site Not Available

Map preview placeholder

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.