Childhood Absence EpilepsyPhase 3NCT06315322
A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants 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 11 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- 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
- 70 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 10 Jul 2024to 16 Nov 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Georgia4 sites
Ep0224 20321
Tbilisi
Ep0224 20322
Tbilisi
Ep0224 20323
Tbilisi
Ep0224 20324
Tbilisi
United States3 sites
Ep0224 50140
Birmingham, Alabama, 35233-2110
Ep0224 50638
New Brunswick, New Jersey, 08901
Ep0224 50640
Winston-Salem, North Carolina, 27157
About this study
Official title: 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
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.
- Being tested
- Brivaracetam Film-coated tablet, Brivaracetam oral solution
- Keywords
- Childhood Absence Epilepsy, Juvenile Absence Epilepsy, Phase 3, Brivaracetam
- Medical subject headings
- Epilepsy, Absence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brivaracetam Film-coated tabletDrug
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.
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.
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).
Measured: 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).
Measured: From Entry Visit up to the Safety Visit (up to 3 years)
Secondary outcomes (2)
Incidence of serious adverse events (SAEs) during the study
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 the Safety Visit (up to 3 years)
Incidence of IMP related 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).
Measured: From Entry Visit up to the Safety Visit (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start10 Jul 2024
- Primary completion16 Nov 2029 (estimated)
- Study completion16 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315322
- Sponsor's protocol ID
- EP0224
- Other IDs
- 2023-508095-11-00, U1111-1303-1174, 2023
- Status last verified
- Aug 2026
- First submitted
- 11 Mar 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. 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 AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSY
- ClinicalTrials.gov ID
- NCT06315322
- Acronym / sponsor ID
- EP0224
- Keywords
- Childhood Absence Epilepsy, Juvenile Absence Epilepsy, Phase 3, Brivaracetam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 16 Nov 2029 (estimated)
- Study completion
- 16 Nov 2029 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
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 and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.
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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
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 tabletDrug: 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 solutionPharmaceutical 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
Incidence of treatment-emergent adverse events (TEAEs) during the study
Time frame: From Entry Visit up to the Safety Visit (up to 3 years)
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).
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study
Time frame: From Entry Visit up to the Safety Visit (up to 3 years)
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).
2 secondary outcomes
Incidence of serious adverse events (SAEs) during the study
Time frame: From Entry Visit up to the Safety Visit (up to 3 years)
Incidence of IMP related TEAEs during the study
Time frame: From Entry Visit up to the Safety Visit (up to 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 5 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 11 sites in 5 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 10 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Georgia, United States, Romania, Italy, Slovakia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of treatment-emergent adverse events (TEAEs) during the study (time frame: From Entry Visit up to the Safety Visit (up to 3 years)). 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 27 Aug 2026.