A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Last updated: April 2, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Completed

Phase

3

Condition

Epilepsy

Seizure Disorders

Treatment

Brivaracetam oral solution

Brivaracetam Film-coated tablet

Clinical Study ID

NCT05109234
EP0132
2020-002769-33
  • Ages 2-26
  • All Genders

Study Summary

The purpose of the study is to investigate the long-term safety, tolerability and efficacy of brivaracetam in pediatric study participants with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who previously participated in N01269 (NCT04666610) and qualify forentry into EP0132 as per N01269 (NCT04666610) protocol with a confirmed diagnosis ofchildhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE), and for whom areasonable benefit from long-term administration of brivaracetam (BRV) is expected,in the opinion of the Investigator

  • A sexually active male study participant must agree to use contraception during thetreatment 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

  • A female study participant is eligible to participate if she is not pregnant, notbreastfeeding, and at least 1 of the following conditions applies:

  1. The study participant is premenarchal OR

  2. A woman of childbearing potential (WOCBP) who agrees to follow thecontraceptive guidance during the treatment period and for at least 2 daysafter the last dose of study medication, corresponding to the time needed toeliminate study treatment

  • Study participant is capable of and provides consent/assent, and the studyparticipant's parent/legal representative/caregiver provides signed informed consentfor minor study participants, which includes compliance with the requirements andrestrictions listed in the informed consent form (ICF) and in this protocol

Exclusion

Exclusion Criteria:

  • Study participant has a history or presence of paroxysmal nonepileptic seizures

  • Study participant has severe medical, neurological, or psychiatric disorders orlaboratory values, which could, at the discretion of the Investigator, affect safeparticipation in the study or would preclude appropriate study participation

  • 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 active suicidal ideation prior to study entry as indicated bya positive response ("Yes") to either Question 4 or Question 5 of the ColumbiaSuicide Severity Rating Scale (C-SSRS) (for study participants 6 years or older) orclinical judgment (for study participants younger than 6 years). The studyparticipant 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 Investigator must immediatelyrefer the study participant to a Mental Healthcare Professional

  • Participant has any medical or psychiatric condition that, in the opinion of theInvestigator, could jeopardize or would compromise the study participant's abilityto participate in this study

  • Participant has a known fructose intolerance or known hypersensitivity to anycomponents of brivaracetam (BRV) or excipients or a drug with similar chemicalstructure. Note that the tablets contain lactose

  • Study participant has end-stage kidney disease requiring dialysis

  • Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine,phenobarbital, phenytoin, tiagabine, or vigabatrin

  • Study participant has planned participation in any clinical study on aninvestigational drug or device

  • Study participant has poor compliance with the visit schedule or medication intakein the core study in the opinion of the Investigator

Study Design

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: Brivaracetam oral solution
Phase: 3
Study Start date:
March 30, 2022
Estimated Completion Date:
March 18, 2025

Connect with a study center

  • Ep0132 400

    Tbilisi,
    Georgia

    Site Not Available

  • Ep0132 401

    Tbilisi,
    Georgia

    Site Not Available

  • Ep0132 402

    Tbilisi,
    Georgia

    Site Not Available

  • Ep0132 403

    Tbilisi,
    Georgia

    Site Not Available

  • Ep0132 405

    Tbilisi,
    Georgia

    Site Not Available

  • Ep0132 323

    Messina,
    Italy

    Site Not Available

  • Ep0132 321

    Milano,
    Italy

    Site Not Available

  • Ep0132 324

    Milano,
    Italy

    Site Not Available

  • Ep0132 320

    Pavia,
    Italy

    Site Not Available

  • Ep0132 322

    Roma,
    Italy

    Site Not Available

  • Ep0132 325

    Roma,
    Italy

    Site Not Available

  • Ep0132 326

    Verona,
    Italy

    Site Not Available

  • Ep0132 562

    Bucuresti,
    Romania

    Site Not Available

  • Ep0132 563

    Bucuresti,
    Romania

    Site Not Available

  • Ep0132 560

    Iasi,
    Romania

    Site Not Available

  • Ep0132 561

    Timişoara, Judeţ Timiş,
    Romania

    Site Not Available

  • Ep0132 632

    Bardejov,
    Slovakia

    Site Not Available

  • Ep0132 630

    Dubnica Nad Vahom,
    Slovakia

    Site Not Available

  • Ep0132 354

    Terrassa,
    Spain

    Site Not Available

  • Ep0132 600

    Dnipro,
    Ukraine

    Site Not Available

  • Ep0132 601

    Dnipro,
    Ukraine

    Site Not Available

  • Ep0132 607

    Uzhgorod,
    Ukraine

    Site Not Available

  • Ep0132 602

    Vinnytsia,
    Ukraine

    Site Not Available

  • Ep0132 607

    Úzhgorod,
    Ukraine

    Site Not Available

  • Ep0132 115

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Ep0132 105

    Orange, California 92868-3874
    United States

    Site Not Available

  • Ep0132 116

    Denver, Colorado 80202
    United States

    Site Not Available

  • Ep0132 110

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Ep0132 100

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Ep0132 109

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Ep0132 106

    Philadelphia, Pennsylvania 19134
    United States

    Site 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.