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New drug could stop absence seizures without extra meds

NCT ID NCT04666610

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 05, 2026 · Updated 6 times

Summary

This study tests whether brivaracetam, taken as an oral solution, can stop absence seizures in people aged 2 to 25 with childhood or juvenile absence epilepsy. Participants receive either the drug or a placebo, and seizure freedom is checked using a 24-hour EEG after 14 days. The goal is to see if brivaracetam alone can control seizures safely.

What this could mean

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

Active substance
brivaracetam (oral solution)
What this could lead to
If successful, brivaracetam could become a new first-line treatment option for children and young adults with absence epilepsy, potentially reducing or stopping seizures without needing other drugs.
What could go wrong
This is a Phase 3 trial, but it is still experimental. The drug may not prove more effective than placebo, and side effects or lack of long-term seizure control are possible. Results may not apply to all patients.

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

153 people

The number who actually took part.

Started

Jul 2021

Finished

Jul 2026

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 25 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: * Study participant is 2 to 25 years of age inclusive, at the time of signing the informed consent. No study participants from 2 to \<4 years of age will be included in Stage 1 * Study participant is diagnosed with either childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE) as defined by the International League Against Epilepsy (ILAE) criteria * Study participants 2 to \<4 years of age and participants who had onset of absence seizures at an age younger than 4 years must have a negative glucose transporter type 1 deficiency syndrome (GLUT1DS) genetic test * Study participant is untreated with antiepileptic drugs (AEDs) or pretreated for absence seizures with a maximum of 2 historical AEDs, but without AED treatment for a period of at least 5 half-lives of the AED before randomization into this study. The UCB study physician should be consulted if in doubt * Study participant has electroencephalogram (EEG) evidence of bilateral synchronous, symmetric generalized paroxysmal spike waves (2.5-6 hertz) with normal background activity and with at least 1 electrographically recorded seizure lasting 3 seconds or more on a 1-hour EEG with hyperventilation (HV) while awake at Visit 1 (V1), or on a historical EEG up to 12 weeks before enrollment * Study participant has a history of clinically evident absence seizures occurring on at least 3 days per week in the 2 weeks prior to enrollment * Study participant is without treatment with psychoactive drugs or on a stable dose for at least 2 weeks prior to randomization * Study participant has normal neurological examination, head size, development and cognition * Body weight is more than or equal to 9 kg * Male and female a) 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 b) 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 premenarchial 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 treatment, corresponding to the time needed to eliminate study treatment * Study participant 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 of nonfebrile seizures other than absence seizures (eg, generalized tonic-clonic seizures or myoclonic seizures) * Study participant has a history of absence status epilepticus * Study participant has a history or presence of paroxysmal nonepileptic seizures * 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 a history of major psychiatric disease or any clinically significant medical condition that would preclude appropriate study participation * 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 judgement (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 study participant should be immediately evaluated by a Mental Healthcare Professional to address safety concerns * Study participant with known fructose intolerance or hypersensitivity of any of the ingredients in brivaracetam oral solution * Study participant has end-stage kidney disease requiring dialysis * Concomitant use of rifampicin/rifampin; prior use must have been stopped at least 2 months before randomization * Concomitant use of strong CYP2C19 inhibitors like fluconazole, fluoxetine and fluvoxamine, prior use must have been stopped at least 1 week before randomization * Study participant has participated in another study of an investigational medicinal product (IMP; and/or an investigational device) within the previous 30 days prior to informed consent * Study participant has clinical or EEG findings not consistent with a diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)

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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

  • N01269 100

    New Brunswick, New Jersey, 08901, United States

  • N01269 101

    Tampa, Florida, 33612, United States

  • N01269 104

    Winter Park, Florida, 32789, United States

  • N01269 105

    Orange, California, 92868-3874, United States

  • N01269 106

    Philadelphia, Pennsylvania, 19134, United States

  • N01269 109

    Winston-Salem, North Carolina, 27109, United States

  • N01269 110

    Augusta, Georgia, 30912, United States

  • N01269 111

    Miami, Florida, 33155-3009, United States

  • N01269 115

    Birmingham, Alabama, 35233, United States

  • N01269 116

    Denver, Colorado, 80202, United States

  • N01269 320

    Pavia, Italy

  • N01269 321

    Milan, Italy

  • N01269 322

    Roma, Italy

  • N01269 323

    Messina, Italy

  • N01269 324

    Milan, Italy

  • N01269 325

    Roma, Italy

  • N01269 326

    Verona, Italy

  • N01269 354

    Terrassa, Spain

  • N01269 400

    Tbilisi, Georgia

  • N01269 401

    Tbilisi, Georgia

  • N01269 402

    Tbilisi, Georgia

  • N01269 403

    Tbilisi, Georgia

  • N01269 405

    Tbilisi, Georgia

  • N01269 560

    Iași, Romania

  • N01269 561

    Timişoara, Judeţ Timiş, Romania

  • N01269 562

    Bucharest, Romania

  • N01269 563

    Bucharest, Romania

  • N01269 600

    Dnipro, Ukraine

  • N01269 601

    Dnipro, Ukraine

  • N01269 602

    Vinnytsia, Ukraine

  • N01269 604

    Kharkiv, Ukraine

  • N01269 607

    Uzhhorod, Ukraine

  • N01269 630

    Dubnica nad Váhom, Slovakia

  • N01269 631

    Nové Zámky, Slovakia

  • N01269 632

    Bardejov, Slovakia

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