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

Phase 3

Completed

Conditions: Childhood Absence Epilepsy
Juvenile Absence Epilepsy

Interventions: Drug: Brivaracetam Film-coated tablet
Drug: Brivaracetam oral solution

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

Inclusion Criteria

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
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
A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
1. The study participant is premenarchal OR
2. 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
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

Exclusion Criteria

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 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months	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 of Study Treatment	From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Serious TEAEs	From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months	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.
Percentage of Participants With Study Drug-related TEAEs	From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months	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.
Percentage of Participants With Absence Seizure Freedom Within 4 Days Prior to or During the 1-hour Electroencephalogram (EEG)	Full Evaluation Visit (6 months), Yearly Evaluation Visit (12 months), Full Evaluation Visit (18 months), Yearly Evaluation Visit (24 months)	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).
Percentage of Participants With Absence Seizure Freedom Based on Daily Seizure Diary Over the Entire Evaluation Period and by 3-month Time Intervals	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)	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.

Trial Locations

Locations (24): Ep0132 115
🇺🇸
Birmingham, Alabama, United States
Ep0132 105
🇺🇸
Orange, California, United States
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
Scroll for more (14 remaining)
Ep0132 115
🇺🇸Birmingham, Alabama, United States