A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
- Conditions
- Childhood Absence EpilepsyJuvenile Absence Epilepsy
- Interventions
- Registration Number
- NCT05109234
- Lead Sponsor
- UCB Biopharma SRL
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
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Participants who previously participated in N01269 (NCT04666610) and qualify for entry into EP0132 as per N01269 (NCT04666610) protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE), and for whom a reasonable benefit from long-term administration of brivaracetam (BRV) is expected, in the opinion of the Investigator
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A sexually active male study participant must agree to use contraception during the treatment period and for at least 2 days, corresponding to the time needed to eliminate study treatment, after the last dose of study treatment and refrain from donating sperm during this period
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A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- The study participant is premenarchal OR
- A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the last dose of study medication, corresponding to the time needed to eliminate study treatment
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Study participant is capable of and provides consent/assent, and the study participant's parent/legal representative/caregiver provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Study participant has a history or presence of paroxysmal nonepileptic seizures
- Study participant has severe medical, neurological, or psychiatric disorders or laboratory values, which could, at the discretion of the Investigator, affect safe participation in the study or would preclude appropriate study participation
- Study participant has a clinically relevant electrocardiogram (ECG) abnormality in the opinion of the Principal Investigator
- Study participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
- Study participant has active suicidal ideation prior to study entry as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) (for study participants 6 years or older) or clinical judgment (for study participants younger than 6 years). The study participant should be referred immediately to a Mental Healthcare Professional
- Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt). The Investigator must immediately refer the study participant to a Mental Healthcare Professional
- Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- Participant has a known fructose intolerance or known hypersensitivity to any components of brivaracetam (BRV) or excipients or a drug with similar chemical structure. Note that the tablets contain lactose
- Study participant has end-stage kidney disease requiring dialysis
- Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin
- Study participant has planned participation in any clinical study on an investigational drug or device
- Study participant has poor compliance with the visit schedule or medication intake in the core study in the opinion of the Investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brivaracetam arm Brivaracetam oral solution Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day. Brivaracetam arm Brivaracetam Film-coated tablet Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day.
- Primary Outcome Measures
Name Time Method Percentage of participants with treatment-emergent adverse events (TEAEs) From Entry Visit up to the Safety Visit (Month 26) 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).
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment From Entry Visit until End of Down-Titration Period (Month 26) 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).
- Secondary Outcome Measures
Name Time Method Percentage of participants with serious adverse events (SAEs) during the study From Entry Visit up to the Safety Visit (Month 26) 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 abovePercentage of participants with absence seizure freedom within 4 days prior to or during the 1-hour electroencephalogram (EEG) at each applicable visit From Full Evaluation Visit (Month 6) up to the Final Visit (Month 24) A 1-hour electroencephalogram (EEG) will be performed. The awake hours from the EEG will be analyzed for absence seizures. Every 1-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 any permitted antiepileptic drugs including benzodiazepine in the 4 days prior to the EEG or during the EEG.
Percentage of participants with study drug-related treatment-emergent adverse events (TEAEs) From Entry Visit up to the Safety Visit (Month 26) 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.
Percentage of participants with absence seizure freedom based on diary over the entire evaluation period and by 3-month time intervals From Entry Visit up to the Final Visit (Month 24) During the study, subjects will keep a diary to record daily seizure activity from Visit 1 until the final visit. Each seizure type experienced will be recorded. The participant will be 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.
Trial Locations
- Locations (24)
Ep0132 115
🇺🇸Birmingham, Alabama, United States
Ep0132 320
🇮🇹Pavia, Italy
Ep0132 322
🇮🇹Roma, Italy
Ep0132 325
🇮🇹Roma, Italy
Ep0132 105
🇺🇸Orange, California, United States
Ep0132 100
🇺🇸New Brunswick, New Jersey, United States
Ep0132 110
🇺🇸Augusta, Georgia, United States
Ep0132 401
🇬🇪Tbilisi, Georgia
Ep0132 402
🇬🇪Tbilisi, Georgia
Ep0132 321
🇮🇹Milano, Italy
Ep0132 109
🇺🇸Winston-Salem, North Carolina, United States
Ep0132 400
🇬🇪Tbilisi, Georgia
Ep0132 403
🇬🇪Tbilisi, Georgia
Ep0132 405
🇬🇪Tbilisi, Georgia
Ep0132 323
🇮🇹Messina, Italy
Ep0132 326
🇮🇹Verona, Italy
Ep0132 562
🇷🇴Bucuresti, Romania
Ep0132 560
🇷🇴Iasi, Romania
Ep0132 561
🇷🇴Timişoara, Judeţ Timiş, Romania
Ep0132 632
🇸🇰Bardejov, Slovakia
Ep0132 630
🇸🇰Dubnica Nad Vahom, Slovakia
Ep0132 600
🇺🇦Dnipro, Ukraine
Ep0132 601
🇺🇦Dnipro, Ukraine
Ep0132 607
🇺🇦Uzhgorod, Ukraine