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Study of brivaracetam as a treatment for childhood and juvenile absence epilepsy in patients aged 2-25 years

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying two types of epilepsy: Childhood Absence Epilepsy and Juvenile Absence Epilepsy. These conditions cause brief periods where a person loses awareness of their surroundings and appears to stare blankly into space. The study will test a medication called brivaracetam (oral solution) to see if it works and is safe for patients between 2 and 25 years of age.

The study will examine how well brivaracetam works when used as the only medication for treating these types of epilepsy. Some participants will receive brivaracetam while others will receive a placebo. The study uses a two-stage design, where after the initial treatment period, some participants who responded well to the treatment will enter a withdrawal phase to further confirm the medication's effectiveness.

The main goal is to find out if brivaracetam can help control absence seizures, which are episodes where a person briefly loses awareness. The study will monitor participants using electroencephalogram (a test that records brain wave patterns) and track how often seizures occur. Throughout the study, researchers will also watch for any side effects to ensure the medication is safe for use in young patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive either brivaracetam oral solution or a placebo (a substance that looks like the medication but contains no active ingredient).

    The treatment begins after completing all required initial examinations.

    During the first 14 days, you will take the assigned medication orally according to the prescribed schedule.

  2. Step 2

    Day 14 evaluation

    On day 14, you will undergo a 24-hour ambulatory EEG (a test that records brain activity over 24 hours).

    Your seizure diary will be reviewed to check for absence seizures in the previous 4 days.

    The medical team will evaluate if you are free from absence seizures.

  3. Step 3

    Continued treatment phase

    Treatment continues until week 12.

    Regular monitoring of your response to the medication will occur.

    You must maintain a seizure diary throughout this period.

  4. Step 4

    Week 12 evaluation

    At week 12, another 24-hour ambulatory EEG will be performed.

    Your seizure diary will be reviewed again.

    The medical team will assess if you remain free from absence seizures.

  5. Step 5

    Randomized withdrawal period

    Some participants may enter a randomized withdrawal period.

    During this phase, some participants will continue the medication while others will switch to placebo.

    Regular monitoring and EEG tests will continue during this period.

  6. Step 6

    Safety monitoring

    Throughout the entire study, you will be monitored for any side effects or adverse reactions.

    Any unusual symptoms or health changes should be reported to the medical team.

    Regular safety assessments will be conducted throughout the study period.

Who can join the trial?

13 criteria

  • Age between 2 and 25 years old at the time of consent signing (participants aged 2-4 years will not be included in Stage 1)
  • Diagnosed with either childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE) according to international criteria
  • For participants under 4 years or those who had seizures starting before age 4, must have a negative test for a specific genetic condition called glucose transporter type 1 deficiency syndrome
  • Either never treated with anti-epileptic medications or previously treated with no more than 2 different medications, with no treatment for at least 5 half-lives before study start
  • Must have specific brain wave patterns on an EEG test showing typical absence seizure activity during a 1-hour recording
  • History of visible absence seizures occurring at least 3 days per week in the 2 weeks before joining the study
  • Either not taking psychoactive medications or on a stable dose for at least 2 weeks before study start
  • Normal neurological examination, head size, development, and thinking ability
  • Body weight must be 9 kg or more
  • For sexually active males: must agree to use contraception during treatment and for 2 days after the last dose
  • For females: must be either before first menstruation OR if able to become pregnant, must agree to use contraception during treatment and for 2 days after the last dose
  • Must not be pregnant or breastfeeding
  • Must provide informed consent (for minors, parent/legal guardian must provide consent)

Who cannot join the trial?

14 criteria

  • Age below 2 years or above 25 years
  • Diagnosed with any type of epilepsy other than Childhood Absence Epilepsy (CAE) or Juvenile Absence Epilepsy (JAE)
  • Currently taking multiple anti-epileptic medications (polytherapy)
  • History of serious allergic reactions to medications similar to brivaracetam
  • Presence of other significant medical conditions that could interfere with the study
  • Participation in another clinical trial within the past 30 days
  • Pregnancy or breastfeeding
  • Inability to follow study procedures or attend scheduled visits
  • History of non-compliance with medical treatments
  • Presence of psychiatric conditions that could affect participation
  • Use of prohibited medications that might interact with the study drug
  • Abnormal laboratory test results that indicate significant health issues
  • History of drug or alcohol abuse within the past 2 years
  • Unable to provide informed consent (or have a legal guardian who can provide consent)
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Investigated drugs

Brivaracetam is an anti-epileptic medication used to treat seizures. In this trial, it is being studied as a standalone treatment (monotherapy) for people with childhood absence epilepsy or juvenile absence epilepsy. This medication works by reducing abnormal electrical activity in the brain that causes absence seizures, which are brief periods where a person appears to blank out or stare into space.

What is already known about the treatment

Brivaracetam - An antiepileptic medication administered orally that is being studied for the treatment of childhood absence epilepsy (CAE) and juvenile absence epilepsy (JAE) in patients aged 2 to 25 years. The drug works by binding to synaptic vesicle protein 2A (SV2A) in the brain, which helps regulate neurotransmitter release and reduces abnormal electrical activity between neurons. As a newer generation antiepileptic drug, brivaracetam belongs to the racetam family of medications and is currently being evaluated as a monotherapy option, meaning it could potentially be used as a standalone treatment for absence seizures.

Investigated diseases

  • Childhood Absence Epilepsy

    A form of epilepsy that typically begins between ages 4 and 10, characterized by brief periods of unconsciousness where the person appears to be staring blankly. During these absence seizures, which typically last 10-15 seconds, the person stops their current activity and is unaware of their surroundings. The seizures can occur multiple times throughout the day, often disrupting daily activities such as school work. This condition typically manifests with a characteristic pattern on EEG recordings.

  • Juvenile Absence Epilepsy

    A type of epilepsy that usually begins between ages 10-17, featuring absence seizures similar to those in childhood absence epilepsy but typically occurring less frequently. The seizures involve brief periods of unconsciousness where the person appears to be daydreaming or staring into space. These episodes typically last 10-20 seconds and can occur several times per day. The condition shows specific electrical patterns in the brain during seizures.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-510428-55-00Protocol codeN01269Estimated enrolment197 patientsSponsorUCB Biopharma

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