A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Last updated: March 27, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Active - Recruiting

Phase

3

Condition

Seizure Disorders

Epilepsy

Treatment

Brivaracetam oral solution

Brivaracetam Film-coated tablet

Clinical Study ID

NCT06315322
EP0224
U1111-1303-1174
2023-508095-11-00
  • Ages > 2
  • All Genders

Study Summary

The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who previously participated in EP0132 (NCT05109234) and/or N01269 (NCT04666610) and qualify for entry into EP0224 as per the EP0132 or N01269 protocolwith a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absenceepilepsy (JAE)

  • Participants for whom a reasonable benefit from long-term administration ofBrivaracetam (BRV) is expected in the opinion of the Investigator

  • Male and female A male participant must agree to use contraception during thetreatment period and for at least 2 days after the final dose of investigationalmedicinal product (IMP) and refrain from donating sperm during this period.

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

◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the final dose of IMP.

  • Capable of and provides informed consent/assent, and the participant's parent/legalrepresentative/caregiver provides signed informed consent for minor participants,which includes compliance with the requirements and restrictions listed in theInformed Consent form (ICF)/Assent form and in this protocol

Exclusion

Exclusion Criteria:

  • Participant has a history or presence of paroxysmal nonepileptic seizures

  • Participant has severe medical, neurological, or psychiatric disorders or laboratoryvalues which could, at the discretion of the Investigator, affect safe participationin the study or would preclude appropriate study participation

  • Participant has hepatic impairment (Child Pugh Score A, B, or C) based on theInvestigator's assessment

  • Participant has active suicidal ideation prior to study entry as indicated by apositive response ("Yes") to either Question 4 or Question 5 of the Columbia-SuicideSeverity Rating Scale (C-SSRS) (for participants 6 years of age or older) orclinical judgment (for participants younger than 6 years of age). The participantshould be referred immediately to a Mental Healthcare Professional

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

  • Participant has known fructose intolerance or a known hypersensitivity to anycomponents of BRV or excipients or a drug with similar chemical structure

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

  • Participant is receiving any investigational drugs or using any experimental devicesin addition to BRV

  • Participant meets a mandatory withdrawal criterion for N01269 or EP0132 or isexperiencing an ongoing Serious adverse event (SAE)

  • Participant has poor compliance with the visit schedule or IMP intake in thepreceding study in the opinion of the Investigator

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Brivaracetam oral solution
Phase: 3
Study Start date:
July 10, 2024
Estimated Completion Date:
March 01, 2030

Connect with a study center

  • Ep0224 20321

    Tbilisi,
    Georgia

    Active - Recruiting

  • Ep0224 20322

    Tbilisi,
    Georgia

    Active - Recruiting

  • Ep0224 20323

    Tbilisi,
    Georgia

    Active - Recruiting

  • Ep0224 20324

    Tbilisi,
    Georgia

    Active - Recruiting

  • Ep0224 40765

    Messina,
    Italy

    Active - Recruiting

  • Ep0224 40144

    Milano,
    Italy

    Active - Recruiting

  • Ep0224 40764

    Pavia,
    Italy

    Active - Recruiting

  • Ep0224 40629

    Roma,
    Italy

    Active - Recruiting

  • Ep0224 40763

    Verona,
    Italy

    Active - Recruiting

  • Ep0224 40767

    Bucharest,
    Romania

    Active - Recruiting

  • Ep0224 40769

    Bucuresti,
    Romania

    Active - Recruiting

  • Ep0224 40768

    Iasi,
    Romania

    Active - Recruiting

  • Ep0224 40770

    Timisoara,
    Romania

    Active - Recruiting

  • Ep0224 40771

    Bardejov,
    Slovakia

    Active - Recruiting

  • Ep0224 40772

    Dubnica Nad Vahom,
    Slovakia

    Active - Recruiting

  • Ep0224 40453

    Terrassa,
    Spain

    Active - Recruiting

  • Ep0224 20328

    Uzhgorod,
    Ukraine

    Active - Recruiting

  • Ep0224 50140

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Ep0224 50639

    Orange, California 92868
    United States

    Active - Recruiting

  • Ep0224 50268

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Ep0224 50544

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Ep0224 50638

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Ep0224 50640

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

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