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 study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
ASST Fatebenefratelli Sacco Milan Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Centrul National Clinic De Recuperare Neuropsihomotorie Copii Dr. Nicolae Robanescu Bucharest Romania
Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi Iasi Romania
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara Timisoara Romania
Universita’ Degli Studi Di Verona Verona Italy
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Ie Muetl saklsy Bardejov Slovakia
Kiltbzdjf sdbtuk Nova Dubnica Slovakia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
10.03.2022
Romania Romania
Not recruiting
10.03.2022
Slovakia Slovakia
Not recruiting
10.03.2022
Spain Spain
Not recruiting
10.03.2022

Trial locations

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.

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 ID:
2023-510428-55-00
Protocol code:
N01269
NCT ID:
NCT04666610
Trial Phase:
Therapeutic use (Phase IV)

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