Trial Outcomes & Findings for 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 (NCT NCT05109234)
NCT ID: NCT05109234
Last Updated: 2025-10-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
84 participants
Primary outcome timeframe
From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Results posted on
2025-10-22
Participant Flow
The study started to enroll participants in March 2022 and concluded in March 2025.
The Participant Flow refers to the Safety Set (SS). Participants who participated in N01269 (NCT04666610) were offered participation in this study.
Participant milestones
| Measure |
Childhood Absence Epilepsy (CAE): Brivaracetam
Participants with CAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of CAE was obtained for pediatric participants in their age range, until a managed access program (MAP) was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the final visit (FV) instead of the early discontinuation visit (EDV) needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the Safety Visit (SV) were not applicable in such a case.
|
Juvenile Absence Epilepsy (JAE): Brivaracetam
Participants with JAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50 kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of JAE was obtained for pediatric participants in their age range, until a MAP was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the FV instead of the EDV needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the SV were not applicable in such a case.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
20
|
|
Overall Study
Evaluation Period (Up to 24 Months)
|
64
|
20
|
|
Overall Study
COMPLETED
|
50
|
14
|
|
Overall Study
NOT COMPLETED
|
14
|
6
|
Reasons for withdrawal
| Measure |
Childhood Absence Epilepsy (CAE): Brivaracetam
Participants with CAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of CAE was obtained for pediatric participants in their age range, until a managed access program (MAP) was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the final visit (FV) instead of the early discontinuation visit (EDV) needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the Safety Visit (SV) were not applicable in such a case.
|
Juvenile Absence Epilepsy (JAE): Brivaracetam
Participants with JAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50 kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of JAE was obtained for pediatric participants in their age range, until a MAP was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the FV instead of the EDV needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the SV were not applicable in such a case.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
5
|
0
|
|
Overall Study
Consent withdrawn by Participant (not due to AE)
|
1
|
0
|
|
Overall Study
Consent withdrawn by parent/guardian (not AE)
|
3
|
4
|
|
Overall Study
Evacuated from Ukraine due to the war
|
2
|
0
|
|
Overall Study
Missed safety visit; study incomplete per protocol
|
1
|
0
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Childhood Absence Epilepsy (CAE): Brivaracetam
n=64 Participants
Participants with CAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of CAE was obtained for pediatric participants in their age range, until a managed access program (MAP) was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the final visit (FV) instead of the early discontinuation visit (EDV) needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the Safety Visit (SV) were not applicable in such a case.
|
Juvenile Absence Epilepsy (JAE): Brivaracetam
n=20 Participants
Participants with JAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50 kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of JAE was obtained for pediatric participants in their age range, until a MAP was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the FV instead of the EDV needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the SV were not applicable in such a case.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.56 years
STANDARD_DEVIATION 2.49 • n=5 Participants
|
13.93 years
STANDARD_DEVIATION 1.64 • n=7 Participants
|
10.60 years
STANDARD_DEVIATION 2.97 • n=5 Participants
|
|
Age, Customized
24 months - <12 years
|
53 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Customized
12 - <18 years
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
57 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other or Mixed
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) monthsPopulation: The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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.
Outcome measures
| Measure |
Childhood Absence Epilepsy (CAE): Brivaracetam
n=64 Participants
Participants with CAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of CAE was obtained for pediatric participants in their age range, until a managed access program (MAP) was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the final visit (FV) instead of the early discontinuation visit (EDV) needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the Safety Visit (SV) were not applicable in such a case.
|
Juvenile Absence Epilepsy (JAE): Brivaracetam
n=20 Participants
Participants with JAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50 kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of JAE was obtained for pediatric participants in their age range, until a MAP was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the FV instead of the EDV needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the SV were not applicable in such a case.
|
|---|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
|
42.2 percentage of participants
|
55.0 percentage of participants
|
PRIMARY outcome
Timeframe: From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) monthsPopulation: The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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.
Outcome measures
| Measure |
Childhood Absence Epilepsy (CAE): Brivaracetam
n=64 Participants
Participants with CAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of CAE was obtained for pediatric participants in their age range, until a managed access program (MAP) was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the final visit (FV) instead of the early discontinuation visit (EDV) needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the Safety Visit (SV) were not applicable in such a case.
|
Juvenile Absence Epilepsy (JAE): Brivaracetam
n=20 Participants
Participants with JAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50 kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of JAE was obtained for pediatric participants in their age range, until a MAP was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the FV instead of the EDV needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the SV were not applicable in such a case.
|
|---|---|---|
|
Percentage of Participants With TEAEs Leading to Discontinuation of Study Treatment
|
3.1 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) monthsPopulation: The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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.
Outcome measures
| Measure |
Childhood Absence Epilepsy (CAE): Brivaracetam
n=64 Participants
Participants with CAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of CAE was obtained for pediatric participants in their age range, until a managed access program (MAP) was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the final visit (FV) instead of the early discontinuation visit (EDV) needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the Safety Visit (SV) were not applicable in such a case.
|
Juvenile Absence Epilepsy (JAE): Brivaracetam
n=20 Participants
Participants with JAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50 kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of JAE was obtained for pediatric participants in their age range, until a MAP was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the FV instead of the EDV needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the SV were not applicable in such a case.
|
|---|---|---|
|
Percentage of Participants With Serious TEAEs
|
3.1 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) monthsPopulation: The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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.
Outcome measures
| Measure |
Childhood Absence Epilepsy (CAE): Brivaracetam
n=64 Participants
Participants with CAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of CAE was obtained for pediatric participants in their age range, until a managed access program (MAP) was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the final visit (FV) instead of the early discontinuation visit (EDV) needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the Safety Visit (SV) were not applicable in such a case.
|
Juvenile Absence Epilepsy (JAE): Brivaracetam
n=20 Participants
Participants with JAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50 kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of JAE was obtained for pediatric participants in their age range, until a MAP was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the FV instead of the EDV needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the SV were not applicable in such a case.
|
|---|---|---|
|
Percentage of Participants With Study Drug-related TEAEs
|
6.3 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: Full Evaluation Visit (6 months), Yearly Evaluation Visit (12 months), Full Evaluation Visit (18 months), Yearly Evaluation Visit (24 months)Population: The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study. Here, overall number of participants analyzed included all participants who were evaluable for this assessment and number analyzed (n) signifies participants who were evaluable at each specified timepoints.
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).
Outcome measures
| Measure |
Childhood Absence Epilepsy (CAE): Brivaracetam
n=56 Participants
Participants with CAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of CAE was obtained for pediatric participants in their age range, until a managed access program (MAP) was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the final visit (FV) instead of the early discontinuation visit (EDV) needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the Safety Visit (SV) were not applicable in such a case.
|
Juvenile Absence Epilepsy (JAE): Brivaracetam
n=20 Participants
Participants with JAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50 kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of JAE was obtained for pediatric participants in their age range, until a MAP was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the FV instead of the EDV needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the SV were not applicable in such a case.
|
|---|---|---|
|
Percentage of Participants With Absence Seizure Freedom Within 4 Days Prior to or During the 1-hour Electroencephalogram (EEG)
FEV: 6 months
|
46.4 percentage of participants
|
70.0 percentage of participants
|
|
Percentage of Participants With Absence Seizure Freedom Within 4 Days Prior to or During the 1-hour Electroencephalogram (EEG)
YEV: 12 months
|
42.6 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants With Absence Seizure Freedom Within 4 Days Prior to or During the 1-hour Electroencephalogram (EEG)
FEV: 18 months
|
38.9 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Absence Seizure Freedom Within 4 Days Prior to or During the 1-hour Electroencephalogram (EEG)
YEV: 24 months
|
26.7 percentage of participants
|
18.2 percentage of participants
|
SECONDARY outcome
Timeframe: 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)Population: The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study. Here, "n" signifies participants who were evaluable at each specified timepoints.
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.
Outcome measures
| Measure |
Childhood Absence Epilepsy (CAE): Brivaracetam
n=64 Participants
Participants with CAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of CAE was obtained for pediatric participants in their age range, until a managed access program (MAP) was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the final visit (FV) instead of the early discontinuation visit (EDV) needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the Safety Visit (SV) were not applicable in such a case.
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Juvenile Absence Epilepsy (JAE): Brivaracetam
n=20 Participants
Participants with JAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50 kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of JAE was obtained for pediatric participants in their age range, until a MAP was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the FV instead of the EDV needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the SV were not applicable in such a case.
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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
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34.4 percentage of participants
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35.0 percentage of participants
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Percentage of Participants With Absence Seizure Freedom Based on Daily Seizure Diary Over the Entire Evaluation Period and by 3-month Time Intervals
Months 4-6
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39.0 percentage of participants
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55.0 percentage of participants
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Percentage of Participants With Absence Seizure Freedom Based on Daily Seizure Diary Over the Entire Evaluation Period and by 3-month Time Intervals
Months 7-9
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37.7 percentage of participants
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57.9 percentage of participants
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Percentage of Participants With Absence Seizure Freedom Based on Daily Seizure Diary Over the Entire Evaluation Period and by 3-month Time Intervals
Months 10-12
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38.8 percentage of participants
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55.6 percentage of participants
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Percentage of Participants With Absence Seizure Freedom Based on Daily Seizure Diary Over the Entire Evaluation Period and by 3-month Time Intervals
Months 13-15
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31.8 percentage of participants
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61.1 percentage of participants
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Percentage of Participants With Absence Seizure Freedom Based on Daily Seizure Diary Over the Entire Evaluation Period and by 3-month Time Intervals
Months 16-18
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35.9 percentage of participants
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56.3 percentage of participants
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Percentage of Participants With Absence Seizure Freedom Based on Daily Seizure Diary Over the Entire Evaluation Period and by 3-month Time Intervals
Months 19-21
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30.3 percentage of participants
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42.9 percentage of participants
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Percentage of Participants With Absence Seizure Freedom Based on Daily Seizure Diary Over the Entire Evaluation Period and by 3-month Time Intervals
Months 22-24
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21.9 percentage of participants
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33.3 percentage of participants
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Percentage of Participants With Absence Seizure Freedom Based on Daily Seizure Diary Over the Entire Evaluation Period and by 3-month Time Intervals
Entire Evaluation Period (up to 24 months)
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28.1 percentage of participants
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30.0 percentage of participants
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Adverse Events
Childhood Absence Epilepsy (CAE): Brivaracetam
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Juvenile Absence Epilepsy (JAE): Brivaracetam
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Childhood Absence Epilepsy (CAE): Brivaracetam
n=64 participants at risk
Participants with CAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of CAE was obtained for pediatric participants in their age range, until a managed access program (MAP) was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the final visit (FV) instead of the early discontinuation visit (EDV) needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the Safety Visit (SV) were not applicable in such a case.
|
Juvenile Absence Epilepsy (JAE): Brivaracetam
n=20 participants at risk
Participants with JAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50 kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of JAE was obtained for pediatric participants in their age range, until a MAP was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the FV instead of the EDV needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the SV were not applicable in such a case.
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Blood and lymphatic system disorders
Lymphadenitis
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1.6%
1/64 • Number of events 1 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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0.00%
0/20 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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Infections and infestations
Measles
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0.00%
0/64 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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5.0%
1/20 • Number of events 1 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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Nervous system disorders
Generalised tonic-clonic seizure
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0.00%
0/64 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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5.0%
1/20 • Number of events 1 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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Nervous system disorders
Status epilepticus
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0.00%
0/64 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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5.0%
1/20 • Number of events 1 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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Psychiatric disorders
Suicidal ideation
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1.6%
1/64 • Number of events 1 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
|
0.00%
0/20 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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Other adverse events
| Measure |
Childhood Absence Epilepsy (CAE): Brivaracetam
n=64 participants at risk
Participants with CAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of CAE was obtained for pediatric participants in their age range, until a managed access program (MAP) was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the final visit (FV) instead of the early discontinuation visit (EDV) needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the Safety Visit (SV) were not applicable in such a case.
|
Juvenile Absence Epilepsy (JAE): Brivaracetam
n=20 participants at risk
Participants with JAE entered the Evaluation Period and received a Brivaracetam (BRV) tablet or oral solution dose of 100 mg/day (or equivalent dose of 2 mg/kg/day for study participants weighing less than 50 kg). The dose could be adjusted after 3 days in the range of 50 to 200 mg/day (or equivalent dose of 1 to 4 mg/kg/day for study participants weighing less than 50 kg) based on the individual needs. The maximum allowed daily dose was 200 mg/day (or equivalent dose of 4 mg/kg/day for study participants weighing less than 50 kg). The duration of the study per study participant was 2 years at minimum, until approval of BRV for the indication of JAE was obtained for pediatric participants in their age range, until a MAP was established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development in the related indication is stopped by the Sponsor, whichever come first. For study participants who transitioned to another BRV study EP0224 (NCT06315322) or a managed access program or similar type of program or who convert to commercial BRV (if, when, and where available), the FV instead of the EDV needed to be completed; however, down-titration (dose reduction to half during 4 weeks) and the SV were not applicable in such a case.
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|---|---|---|
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General disorders
Pyrexia
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6.2%
4/64 • Number of events 4 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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20.0%
4/20 • Number of events 5 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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Nervous system disorders
Petit mal epilepsy
|
14.1%
9/64 • Number of events 10 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
|
25.0%
5/20 • Number of events 8 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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Nervous system disorders
Headache
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4.7%
3/64 • Number of events 4 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
|
10.0%
2/20 • Number of events 3 • From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Treatment-emergent adverse events were defined as AEs that had onset on or after the day of first dose of BRV. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60