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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Brivaracetam
DrugBrivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses. Tablet strengths: 10 mg, 25 mg, 50 mg Route of administration: oral Oral solution Concentration: 10 mg/ml Route of administration: oral
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: BrivaracetamExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of treatment-emergent adverse events (TEAEs) during the study
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.
Time frame
From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)2
Incidence of treatment-emergent serious adverse events (SAEs) during the study
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
Time frame
From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)3
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study
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.
Time frame
From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)Sponsors and contacts
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Source ClinicalTrials.gov