The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
EP0156 is designed to assess the long-term safety and tolerability of BRV in pediatric study participants with epilepsy who participated in the neonatal study N01349 \[NCG03325439\] and/or have participated in the open-label, long-term, follow-up pediatric study N01266 \[NCT01364597\]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Brivaracetam (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
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)
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)
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)
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Ep0156 259
Hawthorne, New York, United States
COMPLETEDEp0156 237
Durham, North Carolina, United States
COMPLETEDEp0156 204
Leuven, Belgium
WITHDRAWNEp0156 240
Prague, Czechia
WITHDRAWNEp0156 207
Loos, France
WITHDRAWNEp0156 209
Freiburg im Breisgau, Germany
WITHDRAWNEp0156 210
Budapest, Hungary
COMPLETEDEp0156 247
Budapest, Hungary
COMPLETEDEp0156 232
Miskolc, Hungary
COMPLETEDEp0156 230
Roma, Italy
COMPLETED...and 26 more locations