The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
* Pharmaceutical form: Oral solution * Route of administration: Oral use Brivaracetam (oral solution \[10 mg/ml, 5 mg/ml or 2.5 mg/ml\] will be administered.
Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Percentage of participants who met the criteria for absence seizure freedom within 4 days prior to or during the 24-hour ambulatory electroencephalogram (EEG) at Day 14
A 24-hour ambulatory electroencephalogram (EEG) will be performed at day 14. The awake hours from the EEG will be analyzed for absence seizures. Every 24-hour EEG will include hyperventilation as a standard provocation test at the beginning of the EEG. Patient will be regarded as not meeting the criteria for absence seizure freedom if they received benzodiazepine in the 4 days prior to the EEG or during the EEG.
Time frame: Day 14
Percentage of participants who met the criteria for absence seizure freedom during the randomized withdrawal (RDW) period as determined by electroencephalogram (EEG)
Study participants (or their care givers) who believe they are experiencing a recurrence of absence seizures will contact the clinical site for a 1-hour EEG (with hyperventilation (HV)). If no absence seizure is observed during this 1hr EEG (locally read), the study participant will receive a 24-hour ambulatory EEG. If an absence seizure is observed during either EEG, the study participant will be considered as not Absence seizure free and leave the study. If no absence seizures are determined by 1/24hr ambulatory EEG the participant will conduct a 24-hour EEG at week 17. Patient will be regarded as not meeting the criteria for absence seizure freedom if they received benzodiazepine in the 4 days prior to the EEG or during the EEG. The awake hours from the EEG will be analyzed for absence seizures. Every 24-hour EEG will include HV as a standard provocation test at the beginning of the EEG.
Time frame: From Week 13 to Week 17
Percent change from Baseline to Day 14 in number of absence seizures on 24-hour ambulatory electroencephalogram (EEG)
A 24-hour ambulatory electroencephalogram (EEG) will be performed at baseline and day 14. The awake hours from the EEG will be analyzed for absence seizures. Every 24-hour EEG will include hyperventilation as a standard provocation test at the beginning of the EEG. This endpoint is the difference between the number of seizures at baseline and Day 14.
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N01269 115
Birmingham, Alabama, United States
RECRUITINGN01269 118
Long Beach, California, United States
WITHDRAWNN01269 105
Orange, California, United States
RECRUITINGN01269 116
Denver, Colorado, United States
COMPLETEDN01269 103
Loxahatchee Groves, Florida, United States
WITHDRAWNN01269 111
Miami, Florida, United States
RECRUITINGN01269 101
Tampa, Florida, United States
COMPLETEDN01269 104
Winter Park, Florida, United States
COMPLETEDN01269 110
Augusta, Georgia, United States
COMPLETEDN01269 100
New Brunswick, New Jersey, United States
RECRUITING...and 43 more locations
Time frame: From Baseline to Day 14
Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Day 14
During the study subjects will keep a diary to record daily seizure activity from Visit 1 until end of the randomized withdrawal (RDW) Period. Each seizure type experienced will be recorded. The last 4 study days prior to Day 14 EEG are used for this endpoint. Patient will be regarded as not meeting the criteria for absence seizure freedom if they received benzodiazepine in the 4 days prior to the EEG or during the EEG.
Time frame: Day 14
Percentage of participants who met the criteria for absence seizure freedom on 24-hour ambulatory electroencephalogram (EEG) at Week 12
A 24-hour ambulatory electroencephalogram (EEG) will be performed at day 14. The awake hours from the EEG will be analyzed for absence seizures. Every 24-hour EEG will include hyperventilation as a standard provocation test at the beginning of the EEG. Patient will be regarded as not meeting the criteria for absence seizure freedom if they received benzodiazepine in the 4 days prior to the EEG or during the EEG.
Time frame: Week 12
Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Week 12
During the study subjects will keep a diary to record daily seizure activity from Visit 1 until end of the randomized withdrawal (RDW) Period. Each seizure type experienced will be recorded. The last 4 study days prior to Week 12 EEG are used for this endpoint. Patient will be regarded as not meeting the criteria for absence seizure freedom if they received benzodiazepine in the 4 days prior to the EEG or during the EEG.
Time frame: Week 12
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).
Time frame: From Day 1 until End of Safety Follow-Up (up to Week 23)
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).
Time frame: From Day 1 until End of Down Titration Period (up to Week 21)
Percentage of participants with 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 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 Screening Period (Day -14 to Day -2) until End of Safety Follow-Up (up to Week 23)
Percentage of participants with drug-related treatment-emergent adverse events (TEAEs) during the study
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP). 'Drug related AEs' are the subset of AEs that the investigator considers as related to the study drug.
Time frame: From Baseline (Day -1) until End of Safety Follow-Up (up to Week 23)