In short
Currently, there are 2 ongoing clinical trials investigating treatments for juvenile absence epilepsy. These trials are testing the medication brivaracetam in patients aged 2 to 25 years. The trials are being conducted across several European countries including Slovakia, Romania, Spain, and Italy. Both studies focus on evaluating the effectiveness and long-term safety of brivaracetam for managing absence seizures in children and young adults.
Clinical trial locations
- Italy
- Romania
- Slovakia
- Spain
Study of brivaracetam as a treatment for childhood and juvenile absence epilepsy in patients aged 2-25 years
This clinical trial is investigating brivaracetam as a standalone treatment for both childhood absence epilepsy and juvenile absence epilepsy. The study is designed to determine whether this medication can effectively control absence seizures, which are brief episodes where a person temporarily loses awareness and appears to stare blankly into space.
Main inclusion criteria:
- Patients between 2 and 25 years old at the time of joining the study
- Confirmed diagnosis of either childhood absence epilepsy or juvenile absence epilepsy according to international criteria
- 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 starting the study
- 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
- Normal neurological examination, head size, development, and thinking ability
- Body weight of 9 kg or more
- For participants under 4 years or those who had seizures starting before age 4, a negative test for glucose transporter type 1 deficiency syndrome is required
Main exclusion criteria:
- Age below 2 years or above 25 years
- Diagnosis of any type of epilepsy other than childhood absence epilepsy or juvenile absence epilepsy
- Currently taking multiple anti-epileptic medications
- History of serious allergic reactions to medications similar to brivaracetam
- Presence of other significant medical conditions that could interfere with the study
- Pregnancy or breastfeeding
- History of drug or alcohol abuse within the past 2 years
- Participation in another clinical trial within the past 30 days
Trial focus and design: The study uses a two-stage design where participants will initially receive either brivaracetam oral solution or a placebo. During the first 14 days, participants will take the assigned medication according to a prescribed schedule. At day 14 and week 12, participants will undergo 24-hour ambulatory EEG tests to monitor brain activity and assess whether they are free from absence seizures. Some participants who respond well to treatment may enter a randomized withdrawal phase to further confirm the medication's effectiveness. Throughout the study, researchers will monitor for any side effects to ensure the medication is safe for young patients.
Investigational drug: Brivaracetam is an anti-epileptic medication that works by reducing abnormal electrical activity in the brain. It binds to synaptic vesicle protein 2A in the brain, which helps regulate neurotransmitter release and reduces abnormal electrical activity between neurons. In this trial, brivaracetam is being studied as a monotherapy option, meaning it could potentially be used as the only treatment for absence seizures.
Study on the Long-Term Safety of Brivaracetam for Children and Young Adults with Childhood or Juvenile Absence Epilepsy
This trial is specifically designed to evaluate the long-term safety and tolerability of brivaracetam in children and young adults over an extended period of up to 36 months. The study aims to provide comprehensive information about how well patients can tolerate this medication over time and what side effects may occur during prolonged use.
Main inclusion criteria:
- Participants must have previously taken part in specific prior studies and qualify for this study based on those protocols
- Confirmed diagnosis of either childhood absence epilepsy or juvenile absence epilepsy
- The study doctor must believe that the participant will benefit from long-term use of brivaracetam
- 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
- Female participants must not be pregnant or breastfeeding and must either be unable to have children or agree to use birth control during the study
- Participants must be able to give informed consent or assent, and for minors, a parent or legal representative must also provide consent
Main exclusion criteria:
- Patients without a diagnosis of childhood absence epilepsy or juvenile absence epilepsy
- Patients not within the specified age range for the study
- Patients unable to follow study procedures or take the study medication as required
- Patients with other medical conditions that might interfere with the study or patient safety
- Patients taking medications that might interfere with the study medication
- History of allergic reactions to brivaracetam or similar medications
- Pregnancy or breastfeeding
- Participation in another clinical trial
Trial focus and design: This is an open-label study, meaning both participants and researchers know which treatment is being administered. Participants will receive brivaracetam in either film-coated tablet or oral solution form. The dosage and frequency are determined by the study protocol and the investigator's assessment. Throughout the study, researchers will conduct regular monitoring for any treatment-emergent adverse events and assess the overall safety and tolerability of long-term brivaracetam use. The study is estimated to conclude by February 28, 2029.
Investigational drug: Brivaracetam is an anticonvulsant medication that is already approved for treating partial-onset seizures in adults and adolescents. It works by binding to synaptic vesicle protein 2A in the brain, which helps stabilize electrical activity and prevent seizures. This study specifically examines its long-term safety profile in children and adolescents with absence epilepsy.
Summary
Both ongoing clinical trials for juvenile absence epilepsy are focused exclusively on evaluating brivaracetam, representing a concentrated research effort on this particular medication. The trials are being conducted across four European countries: Slovakia, Romania, Spain, and Italy, suggesting a coordinated regional approach to studying this treatment option.
The first trial focuses on establishing whether brivaracetam can effectively control absence seizures when used as a standalone treatment, while the second trial extends this investigation by examining the long-term safety profile over a period of up to 36 months. Together, these studies provide complementary information about both the effectiveness and safety of brivaracetam for managing absence epilepsy in young patients.
Notably, the trials cover a broad age range from 2 to 25 years, allowing researchers to gather information about how the medication works across different developmental stages from early childhood through young adulthood. The inclusion of both childhood absence epilepsy and juvenile absence epilepsy in these trials reflects recognition that these related conditions may benefit from similar treatment approaches.
