Childhood Absence EpilepsyPhase 3NCT05109234
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
A Phase 3 study testing Brivaracetam Film-coated tablet and Brivaracetam oral solution in people with Childhood Absence Epilepsy and Juvenile Absence Epilepsy, run by UCB Biopharma SRL at 24 sites in 6 countries.
Trial summary
The purpose of the study is to investigate the long-term safety, tolerability and efficacy of brivaracetam in pediatric study participants with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE). Read more about this study
- Who is it for?
- Ages 2 to 26 years
- Conditions the study is for
- Childhood Absence Epilepsy, Juvenile Absence Epilepsy
- What is being tested?
- Brivaracetam Film-coated tablet and Brivaracetam oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 30 Mar 2022to 18 Mar 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
- The study participant is premenarchal OR
- A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the last dose of study medication, corresponding to the time needed to eliminate study treatment
- 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
Who cannot join
- Study participant has a history or presence of paroxysmal nonepileptic seizures
- Study participant has severe medical, neurological, or psychiatric disorders or laboratory values, which could, at the discretion of the Investigator, affect safe participation in the study or would preclude appropriate study participation
- Study participant has a clinically relevant electrocardiogram (ECG) abnormality in the opinion of the Principal Investigator
- Study participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
- Study participant has active suicidal ideation prior to study entry as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) (for study participants 6 years or older) or clinical judgment (for study participants younger than 6 years). The study participant should be referred immediately to a Mental Healthcare Professional
- Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt). The Investigator must immediately refer the study participant to a Mental Healthcare Professional
Show all 12Show fewer
- Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- Participant has a known fructose intolerance or known hypersensitivity to any components of brivaracetam (BRV) or excipients or a drug with similar chemical structure. Note that the tablets contain lactose
- Study participant has end-stage kidney disease requiring dialysis
- Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin
- Study participant has planned participation in any clinical study on an investigational drug or device
- Study participant has poor compliance with the visit schedule or medication intake in the core study in the opinion of the Investigator
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
Italy6 sites
Ep0132 323
Messina
Ep0132 321
Milan
Ep0132 320
Pavia
Ep0132 322
Roma
Ep0132 325
Roma
Ep0132 326
Verona
United States5 sites
Ep0132 110
Augusta, Georgia, 30912
Ep0132 115
Birmingham, Alabama, 35233
Ep0132 100
New Brunswick, New Jersey, 08901
Ep0132 105
Orange, California, 92868-3874
Ep0132 109
Winston-Salem, North Carolina, 27157
Georgia5 sites
Ep0132 400
Tbilisi
Ep0132 401
Tbilisi
Ep0132 402
Tbilisi
Ep0132 403
Tbilisi
Ep0132 405
Tbilisi
Romania3 sites
Ep0132 562
Bucharest
Ep0132 560
Iași
Ep0132 561
Timişoara, Judeţ Timiş
About this study
Official title: A Multicenter, Open-Label, Single-Arm Study to Evaluate 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
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).
- Being tested
- Brivaracetam Film-coated tablet, Brivaracetam oral solution
- Keywords
- Childhood absence epilepsy, Juvenile absence epilepsy, Brivaracetam, Phase 3, Briviact, CAE, JAE, Epilepsy
- Medical subject headings
- Epilepsy, Absence, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brivaracetam Film-coated tabletDrug
- 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.
Brivaracetam oral solutionDrug
- Pharmaceutical form: Oral solution
- Route of administration: Oral use
Brivaracetam oral solution [10 mg/mL]) will be administered twice per day in equal doses.
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam arm | Experimental | Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day. Receives: Drug: Brivaracetam Film-coated tablet; Drug: Brivaracetam oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start30 Mar 2022
- Primary completion18 Mar 2025
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood Absence EpilepsyStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109234
- Sponsor's protocol ID
- EP0132
- Other IDs
- 2020-002769-33
- Status last verified
- Oct 2025
- First submitted
- 25 Oct 2021
- Last updated
- 22 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Single-Arm Study to Evaluate 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
- ClinicalTrials.gov ID
- NCT05109234
- Acronym / sponsor ID
- EP0132
- Keywords
- Childhood absence epilepsy, Juvenile absence epilepsy, Brivaracetam, Phase 3, Briviact, CAE, JAE, Epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Posted 7 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brivaracetam arm | Experimental | Drug: Brivaracetam Film-coated tablet, Drug: Brivaracetam oral solutionSubjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day. |
Who may qualify
- Ages
- 2 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Study participant has a history or presence of paroxysmal nonepileptic seizures
- Study participant has severe medical, neurological, or psychiatric disorders or laboratory values, which could, at the discretion of the Investigator, affect safe participation in the study or would preclude appropriate study participation
- Study participant has a clinically relevant electrocardiogram (ECG) abnormality in the opinion of the Principal Investigator
- Study participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
- Study participant has active suicidal ideation prior to study entry as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) (for study participants 6 years or older) or clinical judgment (for study participants younger than 6 years). The study participant should be referred immediately to a Mental Healthcare Professional
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Brivaracetam arm |
| Brivaracetam oral solution* 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 arm |
Primary outcome
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. TEAEs are defined as AEs that had onset on or after the day of first dose of BRV.
Percentage of Participants With TEAEs Leading to Discontinuation of Study Treatment
Time frame: From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. TEAEs are defined as AEs that had onset on or after the day of first dose of BRV. Percentage of participants with TEAEs leading to discontinuation were reported.
4 secondary outcomes
Percentage of Participants With Serious TEAEs
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
24 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brivaracetam Film-coated tablet and Brivaracetam oral solution in people with Childhood Absence Epilepsy and Juvenile Absence Epilepsy, run by UCB Biopharma SRL at 24 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy, United States, Georgia, Romania, Ukraine and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.