EpilepsyPhase 3NCT04715646
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
A Phase 3 study testing Brivaracetam in people with Epilepsy, run by UCB Biopharma SRL at 36 sites in 11 countries.
Trial summary
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Brivaracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 36 sitesin 11 countries
- Study dates
- 11 Mar 2021to 8 Jul 2030
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inclusion criteria for long-term follow-up (LTFU) study participants only
- Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439]
- Inclusion criteria for directly enrolled (DE) study participants in Japan only
- Study participant is ≥ 4 years to < 16 years of age
- Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years
- Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED)
- Study participant had at least 1 POS during the 4-week Screening Period
Who cannot join
- Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
- Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV).
- Exclusion criteria for long-term follow-up (LTFU) study participants only
- Study participant ≥ 6 years of age has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS)
- Exclusion criteria for directly enrolled (DE) study participants in Japan only
- Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
Show all 11Show fewer
- Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period
- Study participant has any clinically significant illness
- Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
- Study participant has a clinically significant ECG abnormality
- Study participant had major surgery within 6 months prior to the ScrV
Trial locations and contacts
36 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
36 sites in 11 countries
Japan19 sites, 6 recruiting
- Active, not recruiting
Ep0156 803
Bunkyō City
- Active, not recruiting
Ep0156 808
Chūō
- Active, not recruiting
Ep0156 800
Gifu
- Active, not recruiting
Ep0156 807
Hiroshima
- Recruiting
Ep0156 815
Kodaira-shi
- Active, not recruiting
Ep0156 813
Kōshi
- Active, not recruiting
Ep0156 806
Kyoto
- Active, not recruiting
Ep0156 811
Nagoya
- Active, not recruiting
Ep0156 812
Niigata
- Recruiting
Ep0156 818
Ōbu
- Recruiting
Ep0156 819
Ōmura
- Recruiting
Ep0156 817
Osaka
- Active, not recruiting
Ep0156 805
Sapporo
- Recruiting
Ep0156 816
Sendai
- Active, not recruiting
Ep0156 809
Shimotsuke
- Recruiting
Ep0156 814
Shizuoka
- Active, not recruiting
Ep0156 804
Tokyo
- Active, not recruiting
Ep0156 810
Yokohama
- Completed
Ep0156 802
Yonago
Hungary3 sites
- Completed
Ep0156 210
Budapest
- Completed
Ep0156 247
Budapest
- Completed
Ep0156 232
Miskolc
Mexico3 sites
- Completed
Ep0156 223
Aguascalientes
- Completed
Ep0156 609
Culiacán
- Completed
Ep0156 603
Guadalajara
Poland3 sites
- Completed
Ep0156 406
Kielce
- Completed
Ep0156 402
Krakow
- Completed
Ep0156 401
Poznan
United States2 sites
- Completed
Ep0156 237
Durham, North Carolina, 27710
- Completed
Ep0156 259
Hawthorne, New York, 10532
About this study
Official title: Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
Read the detailed description
EP0156 is designed to assess the long-term safety and tolerability of BRV in pediatric study participants with epilepsy who participated in the neonatal study N01349 [NCG03325439] and/or have participated in the open-label, long-term, follow-up pediatric study N01266 [NCT01364597]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.
- Conditions
- Epilepsy
- Being tested
- Brivaracetam
- Keywords
- Epilepsy, Brivaracetam, Pediatric, Child
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrivaracetamDrug
Also called BRV, Briviact
Brivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses.
Tablet strengths: 10 mg, 25 mg, 50 mg Route of administration: oral
Oral solution Concentration: 10 mg/ml Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam | Experimental | LTFU study participants: Up to 5mg/kg/day (for study participants weighing 11kg to less than 20kg) and up to 4mg/kg/day (for study participants weighing 20kg to less than 50kg) and no more than 200mg/day Directly enrolled (DE) study participants: 1mg/kg/day to 4mg/kg/day and no more than 200mg/day. Receives: Drug: Brivaracetam |
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 any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
Measured: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
Incidence of treatment-emergent 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 inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent disability/incapacity
- Is a congenital anomaly or birth defect
- 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 Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
Measured: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start11 Mar 2021
- Primary completion8 Jul 2030 (estimated)
- Study completion8 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 (estimated)
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
- NCT04715646
- Sponsor's protocol ID
- EP0156
- Other IDs
- 2020-003664-29
- Status last verified
- Jul 2026
- First submitted
- 14 Jan 2021
- Last updated
- 27 Jul 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy
- ClinicalTrials.gov ID
- NCT04715646
- Acronym / sponsor ID
- EP0156
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Brivaracetam, Pediatric, Child
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 8 Jul 2030 (estimated)
- Study completion
- 8 Jul 2030 (estimated)
- First posted
- 20 Jan 2021 (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 evaluate the long-term safety and tolerability of brivaracetam.
Detailed description
EP0156 is designed to assess the long-term safety and tolerability of BRV in pediatric study participants with epilepsy who participated in the neonatal study N01349 [NCG03325439] and/or have participated in the open-label, long-term, follow-up pediatric study N01266 [NCT01364597]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brivaracetam | Experimental | Drug: BrivaracetamLTFU study participants: Up to 5mg/kg/day (for study participants weighing 11kg to less than 20kg) and up to 4mg/kg/day (for study participants weighing 20kg to less than 50kg) and no more than 200mg/day Directly enrolled (DE) study participants: 1mg/kg/day to 4mg/kg/day and no more than 200mg/day. |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Inclusion criteria for long-term follow-up (LTFU) study participants only
- Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439]
- Inclusion criteria for directly enrolled (DE) study participants in Japan only
- Study participant is ≥ 4 years to < 16 years of age
- Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years
Key exclusion criteria (11 listed)
- Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
- Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV).
- Exclusion criteria for long-term follow-up (LTFU) study participants only
- Study participant ≥ 6 years of age has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS)
- Exclusion criteria for directly enrolled (DE) study participants in Japan only
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 |
|---|---|---|
| BrivaracetamAlso: BRV, BriviactBrivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses. Tablet strengths: 10 mg, 25 mg, 50 mg Route of administration: oral Oral solution Concentration: 10 mg/ml Route of administration: oral | Drug | Brivaracetam |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs) during the study
Time frame: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
Incidence of treatment-emergent serious adverse events (SAEs) during the study
Time frame: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * 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
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study
Time frame: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
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 Jul 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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Epilepsy
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.
UCB Cares study director
001 844 599 2273 (UCB)
36 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brivaracetam in people with Epilepsy, run by UCB Biopharma SRL at 36 sites in 11 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Japan, Hungary, Mexico, Poland, United States and 6 more countries. 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?
Contact UCB Cares (0018445992273, UCBCares@ucb.com), or a site near the patient. 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 Evaluation Visit (Day 1) until Safety Visits (up to 5 years)). The study lists 3 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 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.