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Testing the long-term safety of Brivaracetam for childhood and juvenile absence epilepsy

A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSY

Phase 3 Interventional UCB Pharma · NCT06315322

This study is testing how safe and well-tolerated the medication Brivaracetam is for kids and teens with absence epilepsy over a long period.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment120 (estimated)
Ages2 Years and up
SexAll
SponsorUCB Pharma Industry-sponsored
Locations23 sites (Birmingham, Alabama and 22 other locations)
Trial IDNCT06315322 on ClinicalTrials.gov

What this trial studies

This study investigates the long-term safety and tolerability of Brivaracetam in participants diagnosed with childhood absence epilepsy or juvenile absence epilepsy. It involves administering Brivaracetam in both film-coated tablet and oral solution forms to eligible participants who have previously taken part in related studies. The goal is to assess how well the medication can be tolerated over an extended period and its potential benefits for managing these specific types of epilepsy.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with a confirmed diagnosis of childhood absence epilepsy or juvenile absence epilepsy who have previously participated in related studies.

Not a fit: Patients who do not have a diagnosis of childhood absence epilepsy or juvenile absence epilepsy will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term use of Brivaracetam, potentially improving treatment options for children with absence epilepsy.

How similar studies have performed: Other studies have shown promise in evaluating the safety and efficacy of Brivaracetam, suggesting that this approach may yield beneficial results.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)
* Participants for whom a reasonable benefit from long-term administration of Brivaracetam (BRV) is expected in the opinion of the Investigator
* Male and female A male participant must agree to use contraception during the treatment period and for at least 2 days after the final dose of investigational medicinal 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/legal representative/caregiver provides signed informed consent for minor participants, which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF)/Assent form and in this protocol

Exclusion Criteria:

* Participant has a history or presence of paroxysmal nonepileptic seizures
* 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
* Participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
* 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 participants 6 years of age or older) or clinical judgment (for participants younger than 6 years of age). The participant should be referred immediately 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 participant's ability to participate in this study
* Participant has known fructose intolerance or a known hypersensitivity to any components 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 devices in addition to BRV
* Participant meets a mandatory withdrawal criterion for N01269 or EP0132 or is experiencing an ongoing Serious adverse event (SAE)
* Participant has poor compliance with the visit schedule or IMP intake in the preceding study in the opinion of the Investigator

Where this trial is running

Birmingham, Alabama and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Childhood Absence EpilepsyJuvenile Absence EpilepsyPhase 3Brivaracetam
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.