A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSY
3 other identifiers
interventional
120
7 countries
23
Brief Summary
The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2024
Longer than P75 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedStudy Start
First participant enrolled
July 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
April 13, 2026
April 1, 2026
5.6 years
March 11, 2024
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of treatment-emergent adverse events (TEAEs) during the study
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).
From Entry Visit up to the Safety Visit (up to 3 years)
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).
From Entry Visit up to the Safety Visit (up to 3 years)
Secondary Outcomes (2)
Incidence of serious adverse events (SAEs) during the study
From Entry Visit up to the Safety Visit (up to 3 years)
Incidence of IMP related TEAEs during the study
From Entry Visit up to the Safety Visit (up to 3 years)
Study Arms (1)
Brivaracetam arm
EXPERIMENTALSubjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day.
Interventions
Pharmaceutical form: Oral solution Route of administration: Oral use Brivaracetam oral solution \[10 mg/mL\]) will be administered twice per day in equal doses.
Drug: Brivaracetam Film-coated tablet Pharmaceutical form: Film-coated tablet Route of administration: Oral use Brivaracetam film-coated tablet \[10, 25 or 50 mg\] will be administered twice per day in equal doses.
Eligibility Criteria
You may qualify if:
- Participants who previously participated in EP0132 (NCT05109234) and/or N01269 (NCT04666610) and qualify for entry into EP0224 as per the EP0132 or N01269 protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)
- Participants for whom a reasonable benefit from long-term administration of Brivaracetam (BRV) is expected in the opinion of the Investigator
- Male and female A male participant must agree to use contraception during the treatment period and for at least 2 days after the final dose of investigational medicinal product (IMP) and refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- ◦ Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the final dose of IMP.
- \- Capable of and provides informed consent/assent, and the participant's parent/legal representative/caregiver provides signed informed consent for minor participants, which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF)/Assent form and in this protocol
You may not qualify if:
- Participant has a history or presence of paroxysmal nonepileptic seizures
- 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
- Participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
- 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 participants 6 years of age or older) or clinical judgment (for participants younger than 6 years of age). The participant should be referred immediately 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 participant's ability to participate in this study
- Participant has known fructose intolerance or a known hypersensitivity to any components of BRV or excipients or a drug with similar chemical structure
- Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin
- Participant is receiving any investigational drugs or using any experimental devices in addition to BRV
- Participant meets a mandatory withdrawal criterion for N01269 or EP0132 or is experiencing an ongoing Serious adverse event (SAE)
- Participant has poor compliance with the visit schedule or IMP intake in the preceding study in the opinion of the Investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Ep0224 50140
Birmingham, Alabama, 35233-2110, United States
Ep0224 50639
Orange, California, 92868, United States
Ep0224 50268
Miami, Florida, 33155, United States
Ep0224 50638
New Brunswick, New Jersey, 08901, United States
Ep0224 50640
Winston-Salem, North Carolina, 27157, United States
Ep0224 20321
Tbilisi, Georgia
Ep0224 20322
Tbilisi, Georgia
Ep0224 20323
Tbilisi, Georgia
Ep0224 20324
Tbilisi, Georgia
Ep0224 40144
Abbiategrasso, Italy
Ep0224 40765
Messina, Italy
Ep0224 40764
Pavia, Italy
Ep0224 40629
Roma, Italy
Ep0224 40766
Roma, Italy
Ep0224 40763
Verona, Italy
Ep0224 40767
Bucharest, Romania
Ep0224 40769
Bucharest, Romania
Ep0224 40768
Iași, Romania
Ep0224 40770
Timișoara, Romania
Ep0224 40771
Bardejov, Slovakia
Ep0224 40772
Dubnica nad Váhom, Slovakia
Ep0224 40453
Terrassa, Spain
Ep0224 20328
Uzhhorod, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2024
First Posted
March 18, 2024
Study Start
July 10, 2024
Primary Completion (Estimated)
March 1, 2030
Study Completion (Estimated)
March 1, 2030
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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
- Access Criteria
- 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.
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.