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Can a new Add-On seizure drug stay safe for kids over time?

NCT ID NCT04715646

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial is testing the long-term safety of brivaracetam, an anti-seizure medication, when used alongside other epilepsy treatments in children. Researchers are monitoring for side effects, including serious ones, over an extended period. The study includes children who previously took part in related trials, as well as new participants in Japan. The goal is to see if brivaracetam remains safe and tolerable for young patients with epilepsy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brivaracetam (an anti-seizure medication taken by mouth as tablets or oral solution)
What this could lead to
If successful, this could confirm that brivaracetam is safe for long-term use in children with epilepsy, offering a well-tolerated add-on option to control seizures.
What could go wrong
This is an open-label, single-arm study with no placebo group, so results may be less reliable. Side effects like dizziness, drowsiness, or more serious events are possible.

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

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Jul 2030

An estimate. End dates often move.

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

1 month and older

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: Inclusion criteria for long-term follow-up (LTFU) study participants only * Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 \[NCT01364597\] and/or N01349 \[NCT03325439\] Inclusion criteria for directly enrolled (DE) study participants in Japan only * Study participant is ≥ 4 years to \< 16 years of age * Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years * Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED) * Study participant had at least 1 POS during the 4-week Screening Period Exclusion Criteria: Exclusion criteria for all study participants * Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant * Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV). Exclusion criteria for long-term follow-up (LTFU) study participants only \- Study participant ≥ 6 years of age has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS) Exclusion criteria for directly enrolled (DE) study participants in Japan only * Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures * Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period * Study participant has any clinically significant illness * Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results * Study participant has a clinically significant ECG abnormality * Study participant had major surgery within 6 months prior to the ScrV

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Conditions

The condition(s) this trial relates to.

epilepsy

As listed by the trial registrant

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

Epilepsy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ep0156 204

    WITHDRAWN

    Leuven, Belgium

  • Ep0156 207

    WITHDRAWN

    Loos, France

  • Ep0156 209

    WITHDRAWN

    Freiburg im Breisgau, Germany

  • Ep0156 210

    COMPLETED

    Budapest, Hungary

  • Ep0156 223

    COMPLETED

    Aguascalientes, Mexico

  • Ep0156 230

    COMPLETED

    Roma, Italy

  • Ep0156 232

    COMPLETED

    Miskolc, Hungary

  • Ep0156 237

    COMPLETED

    Durham, North Carolina, 27710, United States

  • Ep0156 240

    WITHDRAWN

    Prague, Czechia

  • Ep0156 247

    COMPLETED

    Budapest, Hungary

  • Ep0156 248

    COMPLETED

    Seville, Spain

  • Ep0156 259

    COMPLETED

    Hawthorne, New York, 10532, United States

  • Ep0156 401

    COMPLETED

    Poznan, Poland

  • Ep0156 402

    COMPLETED

    Krakow, Poland

  • Ep0156 406

    COMPLETED

    Kielce, Poland

  • Ep0156 603

    COMPLETED

    Guadalajara, Mexico

  • Ep0156 609

    COMPLETED

    Culiacán, Mexico

  • Ep0156 800

    ACTIVE_NOT_RECRUITING

    Gifu, Japan

  • Ep0156 802

    COMPLETED

    Yonago, Japan

  • Ep0156 803

    ACTIVE_NOT_RECRUITING

    Bunkyō City, Japan

  • Ep0156 804

    ACTIVE_NOT_RECRUITING

    Tokyo, Japan

  • Ep0156 805

    ACTIVE_NOT_RECRUITING

    Sapporo, Japan

  • Ep0156 806

    ACTIVE_NOT_RECRUITING

    Kyoto, Japan

  • Ep0156 807

    ACTIVE_NOT_RECRUITING

    Hiroshima, Japan

  • Ep0156 808

    ACTIVE_NOT_RECRUITING

    Chūō, Japan

  • Ep0156 809

    ACTIVE_NOT_RECRUITING

    Shimotsuke, Japan

  • Ep0156 810

    ACTIVE_NOT_RECRUITING

    Yokohama, Japan

  • Ep0156 811

    ACTIVE_NOT_RECRUITING

    Nagoya, Japan

  • Ep0156 812

    ACTIVE_NOT_RECRUITING

    Niigata, Japan

  • Ep0156 813

    ACTIVE_NOT_RECRUITING

    Kōshi, Japan

  • Ep0156 814

    RECRUITING

    Shizuoka, Japan

  • Ep0156 815

    RECRUITING

    Kodaira-shi, Japan

  • Ep0156 816

    RECRUITING

    Sendai, Japan

  • Ep0156 817

    RECRUITING

    Osaka, Japan

  • Ep0156 818

    RECRUITING

    Ōbu, Japan

  • Ep0156 819

    RECRUITING

    Ōmura, Japan

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