The purpose of the study is to investigate the long-term safety, tolerability and efficacy of brivaracetam in pediatric study participants with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use Brivaracetam film-coated tablet \[10, 25 or 50 mg\] will be administered twice per day in equal doses.
* Pharmaceutical form: Oral solution * Route of administration: Oral use Brivaracetam oral solution \[10 mg/mL\]) will be administered twice per day in equal doses.
Ep0132 115
Birmingham, Alabama, United States
Ep0132 105
Orange, California, United States
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. TEAEs are defined as AEs that had onset on or after the day of first dose of BRV.
Time frame: From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Percentage of Participants With TEAEs Leading to Discontinuation of Study Treatment
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. TEAEs are defined as AEs that had onset on or after the day of first dose of BRV. Percentage of participants with TEAEs leading to discontinuation were reported.
Time frame: From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Percentage of Participants With Serious TEAEs
TEAEs are defined as AEs that had onset on or after the day of first dose of BRV. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, is a congenital anomaly or birth defect, results in permanent or significant disability/incapacity, 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 Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Percentage of Participants With Study Drug-related TEAEs
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. TEAEs are defined as AEs that had onset on or after the day of first dose of BRV. Drug related AEs are the subset of AEs that the investigator considers as related to the study drug.
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Ep0132 110
Augusta, Georgia, United States
Ep0132 100
New Brunswick, New Jersey, United States
Ep0132 109
Winston-Salem, North Carolina, United States
Ep0132 400
Tbilisi, Georgia
Ep0132 401
Tbilisi, Georgia
Ep0132 402
Tbilisi, Georgia
Ep0132 403
Tbilisi, Georgia
Ep0132 405
Tbilisi, Georgia
...and 14 more locations
Time frame: From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Percentage of Participants With Absence Seizure Freedom Within 4 Days Prior to or During the 1-hour Electroencephalogram (EEG)
A 1-hour EEG was performed. The awake hours from the EEG was analyzed for absence seizures. Every 1-hour EEG included hyperventilation as a standard provocation test at the beginning of the EEG. Participant was regarded as not meeting the criteria for absence seizure freedom if they received any permitted antiepileptic drugs including benzodiazepine in the 4 days prior to the EEG or during the EEG. Participants who continue in the study beyond 2 years have their data truncated at Year 2 Month 24 yearly evaluation visit (YEV).
Time frame: Full Evaluation Visit (6 months), Yearly Evaluation Visit (12 months), Full Evaluation Visit (18 months), Yearly Evaluation Visit (24 months)
Percentage of Participants With Absence Seizure Freedom Based on Daily Seizure Diary Over the Entire Evaluation Period and by 3-month Time Intervals
During the study, participants kept a diary to record daily seizure activity from entry visit (Visit 1) until the final visit. Each seizure type experienced were recorded. The participant was considered as not meeting the criteria for absence seizure freedom if they use any permitted anti-epileptic drugs at anytime during the period, and/or complete less than 80% of diaries during the period. Evaluation Period includes all daily seizure diary data over the Evaluation Period up to Month 24 YEV, this includes data from the end of Months 22 to 24 up to the Month 24 YEV where this data is truncated. If a participant does not attend the Month 24 YEV then data was truncated at the last day the participant is in the Evaluation Period in the Month 24 YEV window. Participants who continue in the study beyond 2 years have their data truncated at Year 2 Month 24 YEV, or the last day the participant was in the Evaluation Period in the Month 24 YEV window if this visit is not attended.
Time frame: Months 1-3, Months 4-6, Months 7-9, Months 10-12, Months 13-15, Months 16-18, Months 19-21, Months 22-24 and Entire Evaluation Period (Up to 24 months)