A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

Launched by UCB BIOPHARMA SRL · Jan 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and tolerability of a medication called brivaracetam in children and adolescents with epilepsy, which is a condition that causes seizures. The trial is currently active, meaning they are not looking for new participants at this time. To join the study, participants must be at least 1 month old and have already taken part in earlier studies related to brivaracetam. In Japan, specific participants must be between 4 and 16 years old, have a certain type of epilepsy shown in their EEG test, and experience seizures that have not been controlled by other treatments.

Participants in this trial can expect to be closely monitored for any side effects or issues related to taking brivaracetam over an extended period. It’s important to note that individuals with severe medical or psychological conditions, or those currently involved in other clinical studies, will not be eligible to participate. The study aims to gather valuable information about how well this medication works and how safe it is for young people dealing with epilepsy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Inclusion criteria for long-term follow-up (LTFU) study participants only
• • Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 \[NCT01364597\] and/or N01349 \[NCT03325439\]
• • Inclusion criteria for directly enrolled (DE) study participants in Japan only
• • Study participant is ≥ 4 years to \< 16 years of age
• • Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years
• • Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED)
• • Study participant had at least 1 POS during the 4-week Screening Period
• Exclusion Criteria:
• • Exclusion criteria for all study participants
• • Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
• • Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV).
• • Exclusion criteria for long-term follow-up (LTFU) study participants only
• • - Study participant ≥ 6 years of age has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS)
• • Exclusion criteria for directly enrolled (DE) study participants in Japan only
• • Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
• • Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period
• • Study participant has any clinically significant illness
• • Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
• • Study participant has a clinically significant ECG abnormality
• • Study participant had major surgery within 6 months prior to the ScrV