Study on the Long-Term Safety of Brivaracetam for Children and Young Adults with Childhood or Juvenile Absence Epilepsy

3 1 1

What is this study about?

This clinical trial is focused on studying the long-term safety and tolerability of a medication called brivaracetam in individuals with Childhood Absence Epilepsy or Juvenile Absence Epilepsy. These are types of epilepsy that typically begin in childhood or adolescence and are characterized by brief, sudden lapses in attention or staring spells. The medication being tested, brivaracetam, is available in two forms: a film-coated tablet and an oral solution. It is designed to help manage symptoms associated with these types of epilepsy.

The purpose of the study is to evaluate how safe and well-tolerated brivaracetam is when used over a long period. Participants in the study will receive brivaracetam and will be monitored for any side effects or adverse reactions that may occur during the treatment. The study will also look at how often these side effects lead to participants stopping the medication. The study is open-label, meaning that both the participants and the researchers know which treatment is being administered.

Participants will take brivaracetam for a maximum period of 36 months. Throughout the study, researchers will collect information on any side effects experienced by the participants, including any serious adverse events. This information will help determine the long-term safety of brivaracetam for treating Childhood Absence Epilepsy and Juvenile Absence Epilepsy. The study aims to provide valuable insights into the use of brivaracetam for managing these conditions in children and young adults.

1 joining the study

Participation begins after previous involvement in specific studies and a confirmed diagnosis of childhood or juvenile absence epilepsy.

Eligibility requires a reasonable expectation of benefit from long-term use of brivaracetam.

2 medication administration

The medication brivaracetam is administered orally.

Available forms include film-coated tablets and oral solution.

Dosage and frequency are determined by the study protocol and the investigator’s assessment.

3 monitoring and assessments

Regular monitoring for any treatment-emergent adverse events (TEAEs) is conducted.

Assessments focus on the safety and tolerability of long-term brivaracetam use.

4 completion of study

The study is estimated to conclude by February 28, 2029.

Final evaluations will include the incidence of serious adverse events (SAEs) and any adverse events related to the medication.

Who Can Join the Study?

Participants must have previously taken part in specific studies (EP0132 and/or N01269) and qualify for this study based on those protocols.
Participants must have a confirmed diagnosis of either Childhood Absence Epilepsy (CAE) or Juvenile Absence Epilepsy (JAE). These are types of epilepsy that start in childhood or adolescence and involve brief periods of staring.
The study doctor must believe that the participant will benefit from long-term use of the medication Brivaracetam (BRV).
Both male and female participants are eligible.
Male participants must agree to use birth control during the study and for at least 2 days after the last dose of the study medication. They should also not donate sperm during this time.
Female participants must not be pregnant or breastfeeding. They must either be unable to have children or agree to use birth control during the study and for at least 2 days after the last dose of the study medication.
Participants must be able to give informed consent or assent, which means they understand the study and agree to take part. For minors, a parent or legal representative must also provide consent.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Childhood Absence Epilepsy or Juvenile Absence Epilepsy cannot participate. These are specific types of epilepsy that start in childhood or adolescence and involve brief periods of staring.
Patients who are not within the specified age range for the study cannot participate. The study is for children and adolescents.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other medical conditions that might interfere with the study or the safety of the patient cannot participate.
Patients who are taking medications that might interfere with the study medication cannot participate.
Patients who have a history of allergic reactions to the study medication or similar medications cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are participating in another clinical trial cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia	Bucharest	Romania

Other Sites

Site Name	City	Country
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
Ij Mlphs smledj	Bardejov	Slovakia
Ksoemizlv snvisa	Nova Dubnica	Slovakia

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	30.06.2024
Romania	Not recruiting	30.06.2024
Slovakia	Not recruiting	30.06.2024
Spain	Not recruiting	30.06.2024

Trial locations

Investigated drugs:

Brivaracetam

Brivaracetam is a medication being studied for its long-term safety and tolerability in children and adolescents with childhood absence epilepsy or juvenile absence epilepsy. It is used to help control seizures in these conditions. The study aims to understand how well patients can tolerate this medication over an extended period.

Investigated diseases:

Juvenile absence epilepsy

Childhood Absence Epilepsy – This is a type of epilepsy that typically begins in childhood, characterized by brief, sudden lapses in awareness. These episodes, known as absence seizures, often last only a few seconds and may occur multiple times a day. During a seizure, the child may appear to be staring blankly into space and may not respond to external stimuli. The condition is generally considered to be a form of generalized epilepsy, meaning it affects both sides of the brain. Over time, some children may outgrow the seizures, while others may continue to experience them into adolescence or adulthood.

Juvenile Absence Epilepsy – This form of epilepsy usually begins in adolescence and is marked by absence seizures similar to those seen in childhood absence epilepsy. However, the seizures in juvenile absence epilepsy may be less frequent but tend to last longer. In addition to absence seizures, individuals may also experience generalized tonic-clonic seizures. The condition is part of a group of epilepsy syndromes that affect both sides of the brain. It is important to monitor the progression of the condition as it can impact daily activities and learning.

Trial ID:

2023-508095-11-00

Protocol code:

EP0224

NCT ID:

NCT06315322

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Long-Term Safety of Brivaracetam for Children and Young Adults with Childhood or Juvenile Absence Epilepsy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?