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 27, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Active - 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 ≥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: 160
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
July 29, 2021
Estimated Completion Date:
February 25, 2027

Connect with a study center

  • N01269 203

    Heidelberg,
    Australia

    Site Not Available

  • N01269 202

    Melbourne,
    Australia

    Site Not Available

  • N01269 200

    Randwick,
    Australia

    Site Not Available

  • N01269 201

    South Brisbane,
    Australia

    Site Not Available

  • N01269 301

    Bruxelles,
    Belgium

    Site Not Available

  • N01269 300

    Edegem,
    Belgium

    Site Not Available

  • N01269 400

    Tbilisi,
    Georgia

    Active - Recruiting

  • N01269 401

    Tbilisi,
    Georgia

    Active - Recruiting

  • N01269 402

    Tbilisi,
    Georgia

    Completed

  • N01269 403

    Tbilisi,
    Georgia

    Active - Recruiting

  • N01269 405

    Tbilisi,
    Georgia

    Active - Recruiting

  • N01269 323

    Messina,
    Italy

    Active - Recruiting

  • N01269 321

    Milano,
    Italy

    Active - Recruiting

  • N01269 324

    Milano,
    Italy

    Active - Recruiting

  • N01269 320

    Pavia,
    Italy

    Active - Recruiting

  • N01269 322

    Roma,
    Italy

    Active - Recruiting

  • N01269 325

    Roma,
    Italy

    Active - Recruiting

  • N01269 326

    Verona,
    Italy

    Active - Recruiting

  • N01269 533

    Gdansk,
    Poland

    Site Not Available

  • N01269 533

    Gdańsk,
    Poland

    Site Not Available

  • N01269 530

    Krakow,
    Poland

    Site Not Available

  • N01269 530

    Kraków,
    Poland

    Site Not Available

  • N01269 534

    Lodz,
    Poland

    Site Not Available

  • N01269 531

    Lublin,
    Poland

    Site Not Available

  • N01269 532

    Warszawa,
    Poland

    Site Not Available

  • N01269 534

    Łódź,
    Poland

    Site Not Available

  • N01269 562

    Bucuresti,
    Romania

    Active - Recruiting

  • N01269 563

    Bucuresti,
    Romania

    Active - Recruiting

  • N01269 560

    Iasi,
    Romania

    Active - Recruiting

  • N01269 560

    Iaşi,
    Romania

    Site Not Available

  • N01269 561

    Timişoara,
    Romania

    Site Not Available

  • N01269 561

    Timişoara, Judeţ Timiş,
    Romania

    Active - Recruiting

  • N01269 632

    Bardejov,
    Slovakia

    Active - Recruiting

  • N01269 630

    Dubnica Nad Vahom,
    Slovakia

    Active - Recruiting

  • N01269 631

    Nove Zamky,
    Slovakia

    Completed

  • N01269 351

    Madrid,
    Spain

    Site Not Available

  • N01269 353

    Sevilla,
    Spain

    Site Not Available

  • N01269 354

    Terrassa,
    Spain

    Active - Recruiting

  • N01269 600

    Dnipro,
    Ukraine

    Completed

  • N01269 601

    Dnipro,
    Ukraine

    Site Not Available

  • N01269 604

    Kharkiv,
    Ukraine

    Completed

  • N01269 608

    Kharkiv,
    Ukraine

    Site Not Available

  • N01269 603

    Kyiv,
    Ukraine

    Site Not Available

  • N01269 606

    Kyiv,
    Ukraine

    Site Not Available

  • N01269 607

    Uzhgorod,
    Ukraine

    Completed

  • N01269 602

    Vinnytsia,
    Ukraine

    Completed

  • N01269 607

    Úzhgorod,
    Ukraine

    Site Not Available

  • N01269 115

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • N01269 118

    Long Beach, California 90806
    United States

    Site Not Available

  • N01269 105

    Orange, California 92868-3874
    United States

    Active - Recruiting

  • N01269 116

    Denver, Colorado 80202
    United States

    Completed

  • N01269 103

    Loxahatchee Groves, Florida 33470
    United States

    Site Not Available

  • N01269 111

    Miami, Florida 33155-3009
    United States

    Active - Recruiting

  • 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

    Completed

  • N01269 Site 103

    Wellington, Florida 33414
    United States

    Site Not Available

  • N01269 104

    Winter Park, Florida 32789
    United States

    Completed

  • N01269 110

    Augusta, Georgia 30912
    United States

    Completed

  • N01269 100

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • N01269 109

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • N01269 106

    Philadelphia, Pennsylvania 19134
    United States

    Completed

  • N01269 Site 106

    Philadelphia, Pennsylvania 19134
    United States

    Site Not Available

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