A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
ConditionEpilepsy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1+
SponsorUCB Biopharma SRL
About this trial
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
Eligibility criteria
Qualifiers
Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439]
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)
Disqualifiers
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).
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
Trial design
Treatments tested in this trial
- Brivaracetam
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov