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New epilepsy drug shows promise for kids in Long-Term trial

NCT ID NCT05109234

Disease control Sponsor: UCB Biopharma SRL Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety and tolerability of the drug brivaracetam in 84 children and young adults (ages 2 to 26) with childhood or juvenile absence epilepsy. Participants who had already been in a previous study were given brivaracetam and monitored for side effects. The goal was to see if the drug is safe and well-tolerated over an extended period.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

84 people

The number who actually took part.

Started

Mar 2022

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 26 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. The study participant is premenarchal OR 2. 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

childhood absence epilepsy epilepsy Epilepsy, Absence juvenile absence epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Childhood absence epilepsy Juvenile absence epilepsy

Contacts and locations

Locations

  • Ep0132 100

    New Brunswick, New Jersey, 08901, United States

  • Ep0132 105

    Orange, California, 92868-3874, United States

  • Ep0132 109

    Winston-Salem, North Carolina, 27157, United States

  • Ep0132 110

    Augusta, Georgia, 30912, United States

  • Ep0132 115

    Birmingham, Alabama, 35233, United States

  • Ep0132 320

    Pavia, Italy

  • Ep0132 321

    Milan, Italy

  • Ep0132 322

    Roma, Italy

  • Ep0132 323

    Messina, Italy

  • Ep0132 325

    Roma, Italy

  • Ep0132 326

    Verona, Italy

  • Ep0132 400

    Tbilisi, Georgia

  • Ep0132 401

    Tbilisi, Georgia

  • Ep0132 402

    Tbilisi, Georgia

  • Ep0132 403

    Tbilisi, Georgia

  • Ep0132 405

    Tbilisi, Georgia

  • Ep0132 560

    Iași, Romania

  • Ep0132 561

    Timişoara, Judeţ Timiş, Romania

  • Ep0132 562

    Bucharest, Romania

  • Ep0132 600

    Dnipro, Ukraine

  • Ep0132 601

    Dnipro, Ukraine

  • Ep0132 607

    Uzhhorod, Ukraine

  • Ep0132 630

    Dubnica nad Váhom, Slovakia

  • Ep0132 632

    Bardejov, Slovakia

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