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

Completed · Phase 3

Conditions studied: Childhood Absence Epilepsy, Juvenile Absence Epilepsy

In brief

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).

Key facts

Study ID

NCT05109234

Run by

UCB Biopharma SRL

People needed

84

Starts

2022-03-30

Expected to finish

2025-03-18

Last updated by the study team

2025-10-22

Who can join

Age: 2 and older, up to 26. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who previously participated in N01269 (NCT04666610) and qualify for entry into EP0132 as per N01269 (NCT04666610) protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE), and for whom a reasonable 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 the treatment period and for at least 2 days, corresponding to the time needed to eliminate study treatment, after the last dose of study treatment and refrain from donating sperm during this period
• A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
• The study participant is premenarchal OR
• A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the last dose of study medication, corresponding to the time needed to eliminate study treatment
• Study participant is capable of and provides consent/assent, and the study participant's parent/legal representative/caregiver provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

You may not qualify if…

• Study participant has a history or presence of paroxysmal nonepileptic seizures
• Study participant has severe medical, neurological, or psychiatric disorders or laboratory values, which could, at the discretion of the Investigator, affect safe participation in the study or would preclude appropriate study participation
• Study participant has a clinically relevant electrocardiogram (ECG) abnormality in the opinion of the Principal Investigator
• Study participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
• Study participant has active suicidal ideation prior to study entry as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) (for study participants 6 years or older) or clinical judgment (for study participants younger than 6 years). The study participant should be referred immediately to a Mental Healthcare Professional
• Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt). The Investigator must immediately refer the study participant to a Mental Healthcare Professional
• Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
• Participant has a known fructose intolerance or known hypersensitivity to any components of brivaracetam (BRV) or excipients or a drug with similar chemical structure. 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 an investigational drug or device
• Study participant has poor compliance with the visit schedule or medication intake in the core study in the opinion of the Investigator

Where it is running

• Ep0132 115 — Birmingham, Alabama, United States
• Ep0132 105 — Orange, California, United States
• Ep0132 110 — Augusta, Georgia, United States
• Ep0132 100 — New Brunswick, New Jersey, United States
• Ep0132 109 — Winston-Salem, North Carolina, United States
• Ep0132 400 — Tbilisi, Georgia
• Ep0132 401 — Tbilisi, Georgia
• Ep0132 402 — Tbilisi, Georgia
• Ep0132 403 — Tbilisi, Georgia
• Ep0132 405 — Tbilisi, Georgia
• Ep0132 323 — Messina, Italy
• Ep0132 321 — Milan, Italy
• Ep0132 320 — Pavia, Italy
• Ep0132 322 — Roma, Italy
• Ep0132 325 — Roma, Italy
• Ep0132 326 — Verona, Italy
• Ep0132 562 — Bucharest, Romania
• Ep0132 560 — Iași, Romania
• Ep0132 561 — Timişoara, Judeţ Timiş, Romania
• Ep0132 632 — Bardejov, Slovakia
• Ep0132 630 — Dubnica nad Váhom, Slovakia
• Ep0132 600 — Dnipro, Ukraine
• Ep0132 601 — Dnipro, Ukraine
• Ep0132 607 — Uzhhorod, Ukraine

Full record on ClinicalTrials.gov

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