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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002769-33 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivaracetam arm | Experimental | Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivaracetam Film-coated tablet | Drug |
Brivaracetam film-coated tablet [10, 25 or 50 mg] will be administered twice per day in equal doses. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ep0132 115 | Birmingham | Alabama | 35233 | United States | ||
| Ep0132 105 |
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
The Participant Flow refers to the Safety Set (SS). Participants who participated in N01269 (NCT04666610) were offered participation in this study.
The study started to enroll participants in March 2022 and concluded in March 2025.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2021 | Aug 11, 2025 |
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| Brivaracetam oral solution | Drug |
Brivaracetam oral solution [10 mg/mL]) will be administered twice per day in equal doses. |
|
| 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. | 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). | 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. | 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) |
| Orange |
| California |
| 92868-3874 |
| United States |
| Ep0132 110 | Augusta | Georgia | 30912 | United States |
| Ep0132 100 | New Brunswick | New Jersey | 08901 | United States |
| Ep0132 109 | Winston-Salem | North Carolina | 27157 | United States |
| Ep0132 400 | Tbilisi | Georgia |
| Ep0132 401 | Tbilisi | Georgia |
| Ep0132 402 | Tbilisi | Georgia |
| Ep0132 403 | Tbilisi | Georgia |
| Ep0132 405 | Tbilisi | Georgia |
| Ep0132 323 | Messina | Italy |
| Ep0132 321 | Milan | Italy |
| Ep0132 320 | Pavia | Italy |
| Ep0132 322 | Roma | Italy |
| Ep0132 325 | Roma | Italy |
| Ep0132 326 | Verona | Italy |
| Ep0132 562 | Bucharest | Romania |
| Ep0132 560 | Iași | Romania |
| Ep0132 561 | Timişoara, Judeţ Timiş | Romania |
| Ep0132 632 | Bardejov | Slovakia |
| Ep0132 630 | Dubnica nad Váhom | Slovakia |
| Ep0132 600 | Dnipro | Ukraine |
| Ep0132 601 | Dnipro | Ukraine |
| Ep0132 607 | Uzhhorod | Ukraine |
| FG001 | 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. |
| Evaluation Period (Up to 24 Months) | Participants who were enrolled in the study will enter the Evaluation Period and received the BRV dose. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the long-term follow-up (LTFU) study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study. | Posted | Number | percentage of participants | From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months |
|
|
| |||||||||||||||||||||||||||||
| Primary | 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. | The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study. | Posted | Number | percentage of participants | From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months |
| |||||||||||||||||||||||||||||||
| Secondary | 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. | The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study. | Posted | Number | percentage of participants | From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months |
| |||||||||||||||||||||||||||||||
| Secondary | 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. | The SS consisted of all enrolled study participants who took at least 1 dose of study drug in the LTFU study. | Posted | Number | percentage of participants | From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months |
| |||||||||||||||||||||||||||||||
| Secondary | 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). | 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. | Posted | Number | percentage of participants | Full Evaluation Visit (6 months), Yearly Evaluation Visit (12 months), Full Evaluation Visit (18 months), Yearly Evaluation Visit (24 months) |
| |||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | percentage of participants | 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) |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 64 | 2 | 64 | 15 | 64 |
| EG001 | 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. | 0 | 20 | 2 | 20 | 8 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA version 18.1 | Non-systematic Assessment |
| |
| Measles | Infections and infestations | MedDRA version 18.1 | Non-systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA version 18.1 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA version 18.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA version 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA version 18.1 | Non-systematic Assessment |
| |
| Petit mal epilepsy | Nervous system disorders | MedDRA version 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 18.1 | Non-systematic Assessment |
|
EP0132 enrolled fewer participants than expected (approximately 140) so it was closed prematurely, followed by the initiation of the managed access program EP0225 (NCTID not applicable) and its replacement with the new open-label study EP0224 (NCT06315322).
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2024 | Aug 11, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004832 | Epilepsy, Absence |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
Not provided
Not provided
| ID | Term |
|---|---|
| C482793 | brivaracetam |
Not provided
Not provided
Not provided
| 12 - <18 years |
|
| Male |
|
| Black or African American |
|
| White |
|
| Other or Mixed |
|
| Not Hispanic or Latino |
|
| OG001 | 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. |
|
|
| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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