Brivaracetam for Seizures in Children and Adolescents
This study is testing the long-term safety of brivaracetam, a medication given as tablets or an oral solution, for children and adolescents with epilepsy (a brain disorder that causes seizures). Researchers want to see how often side effects happen and how serious they are over a long period, up to 5 years. You might be able to join if you are at least 1 month old and have participated in previous brivaracetam studies (N01266 or N01349). In Japan, children aged 4 to under 16 with partial-onset seizures can join directly. The study plans to enroll about 70 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive brivaracetam. It plans to enroll about 70 participants.
- What's involved
- Brivaracetam tablets or oral solution will be taken twice daily. You will have evaluation visits and safety visits for up to 5 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety events from the first evaluation visit until safety visits, which can last up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
At a glance
Conditions
Where it's being run
36 sites across 12 statesStudy leadership
- UCB Cares · STUDY_DIRECTOR · 001 844 599 2273 (UCB)
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Incidence of treatment-emergent adverse events (TEAEs) during the studyFrom Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
- Incidence of treatment-emergent serious adverse events (SAEs) during the studyFrom Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
- Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the studyFrom Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.