Partial Seizures With or Without Secondary GeneralizationPhase 3NCT03250377
A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
A Phase 3 study testing Brivaracetam in people with Partial Seizures With or Without Secondary Generalization and Epilepsy, run by UCB Biopharma SRL at 59 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the long-term safety and tolerability of Brivaracetam (BRV) in focal epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV over time. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Partial Seizures With or Without Secondary Generalization, 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
- 207 participants
- Where
- 59 sitesin 2 countries
- Study dates
- 5 Aug 2017to 24 Dec 2024
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male/female study participant from 16 years of age or older. Study participant who are not legal adults may only be included where legally permitted and ethically accepted
- Study participant completed the Treatment Period and Transition Period of EP0083 or is ongoing in N01379 sites in Japan
- Female study participants with childbearing potential are eligible if they use a medically accepted contraceptive method
- Inclusion Criteria for directly enrollers only: Study participant has 1 to <8 partial seizures (according to the 1981 International League Against Epilepsy (ILAE) classification) during the 8 weeks prior to brivaracetam (BRV) administration
Who cannot join
- Study participant has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study
- Severe medical, neurological or psychiatric disorders, or laboratory values which may have an impact on the safety of the study participant
- Poor compliance with the visit schedule or medication intake in the previous BRV studies
- Planned participation in any other clinical study of another investigational drug or device during this study
- Pregnant or lactating woman
- Any medical condition which, in the Investigator's opinion, warrants exclusion
- Study participant has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
- Study participant has >2 x upper limit of normal (ULN) of any of the following at the Entry Visit (EV): alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5x ULN total bilirubin if known Gilbert's syndrome)
Trial locations and contacts
59 sites in 2 countries.
59 sites in 2 countries
Japan40 sites
Ep0085 148
Adachi-ku
Ep0085 116
Asaka
Ep0085 126
Bunkyō City
Ep0085 127
Bunkyō City
Ep0085 122
Hachinohe
Ep0085 111
Hamamatsu
Ep0085 141
Higashisonogi-gun Kawatana-cho
Ep0085 110
Hiroshima
Ep0085 121
Itami
Ep0085 102
Kagoshima
Ep0085 142
Kamakura
Ep0085 140
Kawasaki
Ep0085 123
Kodaira
Ep0085 115
Kokubunji
Ep0085 132
Kōriyama
Ep0085 112
Kōshi
Ep0085 128
Kurume
Ep0085 124
Kyoto
Ep0085 147
Kyoto
Ep0085 105
Nagakute
Ep0085 118
Nagoya
Ep0085 136
Nagoya
Ep0085 117
Nara
Ep0085 129
Neyagawa
Ep0085 106
Niigata
Ep0085 850
Osaka
Ep0085 130
Ôsaka
Ep0085 131
Ōtsu
Ep0085 114
Saitama
Ep0085 101
Sapporo
Ep0085 103
Sendai
Ep0085 144
Shinjuku-ku
Ep0085 104
Shizuoka
Ep0085 108
Suita
Ep0085 137
Suita
Ep0085 138
Tsukuba
Ep0085 133
Ushiku
Ep0085 109
Yamagata
Ep0085 120
Yokohama
Ep0085 150
Yokohama
China19 sites
Ep0085 905
Beijing
Ep0085 901
Chengdu
Ep0085 902
Guangzhou
Ep0085 909
Guangzhou
Ep0085 917
Guangzhou
Ep0085 920
Guangzhou
Ep0085 924
Guangzhou
Ep0085 912
Hangzhou
Ep0085 908
Lanzhou
Ep0085 921
Nanchang
Ep0085 926
Pingxiang
Ep0085 910
Shijiazhuang
Ep0085 925
Suzhou
Ep0085 913
Wenzhou
Ep0085 930
Xinxiang
Ep0085 916
Yinchuan
Ep0085 918
Zhanjiang
Ep0085 904
Zhengzhou
Ep0085 923
Zunyi
About this study
Official title: An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
The purpose of the study is to evaluate the long-term safety and tolerability of Brivaracetam (BRV) in focal epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV over time.
- Being tested
- Brivaracetam
- Keywords
- Brivaracetam, Epilepsy, Partial seizures with or without secondary generalization, Briviact
- 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 Briviact
- Pharmaceutical form: Film-coated tablet
- Concentration: 25 mg and 50 mg
- Route of administration: Oral use
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam | Experimental | Subjects randomized to this arm will receive open-label Brivaracetam Receives: Drug: Brivaracetam |
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 adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs (TEAEs) were defined as AEs that had onset on or after the day of first BRV dose in EP0085 study.
Measured: From Baseline until end of the safety follow up (up to 88.5 months)
Secondary outcomes (10)
Percent Change in Partial Seizure Frequency (PSF) Per 28 Days From Baseline of EP0083 or N01358 to the Evaluation Period for Rollover Study Participants
The seizure frequency was calculated as number of seizures per 28 days. Percent change of 28 day PSF from Baseline was defined as the percentage reduction of 28 day PSF for a designated post-baseline period in EP0085 compared with the Baseline 28 day PSF in the core study. Change in seizure frequency from Baseline was calculated: percent change = ([Baseline 28 day PSF - Post Baseline 28 day PSF]/[Baseline 28 day PSF]) × 100. For rollovers, the Baseline period was obtained from the core studies of EP0083 and N01358 directly. A negative value in percent change from Baseline indicates a decrease in PSF from Baseline. Evaluation Period values for seizure frequency were calculated from the seizure diary data collected during the Evaluation Period on/after the first BRV administration.
Measured: Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period
50 Percent (%) Responder Rate in Partial Seizure Frequency Per 28 Days From Baseline of EP0083 or N01358 to the Evaluation Period for Rollover Study Participants
The seizure frequency was calculated as number of seizures per 28 days. 50% responders were defined as a participant with a >= 50% reduction in seizure frequency from the baseline period over the post-baseline period. Percentages are based on the number of participants who performed the seizure assessment at each time point. Evaluation Period values for seizure frequency were calculated from the seizure diary data collected during the Evaluation Period on/after the first BRV administration.
Measured: Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period
Percent Change in Partial Seizure Frequency Per 28 Days From Baseline of Directly Enrolled Study Participants to the Evaluation Period
The seizure frequency was calculated as number of seizures per 28 days. For direct enrollers, the Baseline Period was defined as seizure counts collected from 8 weeks prior to the first BRV administration in EP0085. Change in seizure frequency is calculated as the seizure frequency at the evaluation time point minus the seizure frequency at Baseline of directly enrolled participants. A negative value in percent change from Baseline indicates a decrease in PSF from Baseline. Evaluation Period values for seizure frequency were calculated from the seizure diary data collected during the Evaluation Period on/after the first BRV administration.
Measured: Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation Period
50 % Responder Rate in Partial Seizure Frequency Per 28 Days Over the Evaluation Period for Directly Enrolled Study Participants
The seizure frequency for directly enrolled participants was calculated as number of seizures per 28 days from 8 weeks prior to BRV administration. 50% responders were defined as a participant with a >= 50% reduction in seizure frequency from the Baseline Period over the post-baseline period. Percentages are based on the number of participants who performed the seizure assessment at each time point. For direct enrollers, the Baseline Period was defined as seizure counts collected from 8 weeks prior to the first BRV administration in EP0085. Evaluation Period values for seizure frequency were calculated from the seizure diary data collected during the Evaluation Period on/after the first BRV administration.
Measured: Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation Period
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 6 Months During the Evaluation Period for Rollover Study Participants
A study participant was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period and if met all of the following criteria: - the participant completed the designated period during the Evaluation Period - the participant has at least 90% non-missing diary days during the period of time - the participant did not report any seizures during the period.
Measured: During the Evaluation Period (up to 84 months)
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 12 Months During the Evaluation Period for Rollover Study Participants
A study participant was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period and if met all of the following criteria: - the participant completed the designated period during the Evaluation Period - the participant has at least 90% non-missing diary days during the period of time - the participant did not report any seizures during the period.
Measured: During the Evaluation Period (up to 84 months)
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Rollover Study Participants
A study participant was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period and if met all of the following criteria: - the participant completed the designated period during the Evaluation Period - the participant has at least 90% non-missing diary days during the period of time - the participant did not report any seizures during the period.
Measured: During the Evaluation Period (up to 84 months)
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 6 Months During the Evaluation Period for Directly Enrolled Study Participants
A study participant was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period and if met all of the following criteria: - the participant completed the designated period during the Evaluation Period - the participant has at least 90% non-missing diary days during the period of time - the participant did not report any seizures during the period.
Measured: During the Evaluation Period (up to 39 months)
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 12 Months During the Evaluation Period for Directly Enrolled Study Participants
A study participant was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period and if met all of the following criteria: - the participant completed the designated period during the Evaluation Period - the participant has at least 90% non-missing diary days during the period of time - the participant did not report any seizures during the period.
Measured: During the Evaluation Period (up to 39 months)
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Directly Enrolled Study Participants
A study participant was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period and if met all of the following criteria: - the participant completed the designated period during the Evaluation Period - the participant has at least 90% non-missing diary days during the period of time - the participant did not report any seizures during the period.
Measured: During the Evaluation Period (up to 39 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start5 Aug 2017
- Primary completion24 Dec 2024
- Study completion24 Dec 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial Seizures With or Without Secondary GeneralizationStudies 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
- 207 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
- NCT03250377
- Sponsor's protocol ID
- EP0085
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2017
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fujimoto A, Qin B, Bourikas D, Dickson N, Moseley B, Sano T, Soma T, Sun W, Watanabe J, Zhou D, Inoue Y. Safety, Tolerability, and Efficacy of Adjunctive Brivaracetam in Japanese and Chinese Patients with Focal-Onset Seizures: Interim Analysis of a Phase 3 Open-Label Extension Trial. Adv Ther. 2025 Sep;42(9):4335-4349. doi: 10.1007/s12325-025-03253-0. Epub 2025 Jun 23.
PubMed 40549270
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
- ClinicalTrials.gov ID
- NCT03250377
- Acronym / sponsor ID
- EP0085
- Keywords
- Brivaracetam, Epilepsy, Partial seizures with or without secondary generalization, Briviact
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2017 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Posted 29 Jul 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 evaluate the long-term safety and tolerability of Brivaracetam (BRV) in focal epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV over time.
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: BrivaracetamSubjects randomized to this arm will receive open-label Brivaracetam |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male/female study participant from 16 years of age or older. Study participant who are not legal adults may only be included where legally permitted and ethically accepted
- Study participant completed the Treatment Period and Transition Period of EP0083 or is ongoing in N01379 sites in Japan
- Female study participants with childbearing potential are eligible if they use a medically accepted contraceptive method
- Inclusion Criteria for directly enrollers only: Study participant has 1 to <8 partial seizures (according to the 1981 International League Against Epilepsy (ILAE) classification) during the 8 weeks prior to brivaracetam (BRV) administration
Key exclusion criteria (8 listed)
- Study participant has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study
- Severe medical, neurological or psychiatric disorders, or laboratory values which may have an impact on the safety of the study participant
- Poor compliance with the visit schedule or medication intake in the previous BRV studies
- Planned participation in any other clinical study of another investigational drug or device during this study
- Pregnant or lactating woman
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: Briviact* Pharmaceutical form: Film-coated tablet * Concentration: 25 mg and 50 mg * Route of administration: Oral use | Drug | Brivaracetam |
Primary outcome
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From Baseline until end of the safety follow up (up to 88.5 months)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs (TEAEs) were defined as AEs that had onset on or after the day of first BRV dose in EP0085 study.
10 secondary outcomes
Percent Change in Partial Seizure Frequency (PSF) Per 28 Days From Baseline of EP0083 or N01358 to the Evaluation Period for Rollover Study Participants
Time frame: Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period
50 Percent (%) Responder Rate in Partial Seizure Frequency Per 28 Days From Baseline of EP0083 or N01358 to the Evaluation Period for Rollover Study Participants
Time frame: Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period
Percent Change in Partial Seizure Frequency Per 28 Days From Baseline of Directly Enrolled Study Participants to the Evaluation Period
Time frame: Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation Period
50 % Responder Rate in Partial Seizure Frequency Per 28 Days Over the Evaluation Period for Directly Enrolled Study Participants
Time frame: Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation Period
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 6 Months During the Evaluation Period for Rollover Study Participants
Time frame: During the Evaluation Period (up to 84 months)
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 12 Months During the Evaluation Period for Rollover Study Participants
Time frame: During the Evaluation Period (up to 84 months)
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Rollover Study Participants
Time frame: During the Evaluation Period (up to 84 months)
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 6 Months During the Evaluation Period for Directly Enrolled Study Participants
Time frame: During the Evaluation Period (up to 39 months)
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 12 Months During the Evaluation Period for Directly Enrolled Study Participants
Time frame: During the Evaluation Period (up to 39 months)
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Directly Enrolled Study Participants
Time frame: During the Evaluation Period (up to 39 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40549270Fujimoto A, Qin B, Bourikas D, Dickson N, Moseley B, Sano T, Soma T, Sun W, Watanabe J, Zhou D, Inoue Y. Safety, Tolerability, and Efficacy of Adjunctive Brivaracetam in Japanese and Chinese Patients with Focal-Onset Seizures: Interim Analysis of a Phase 3 Open-Label Extension Trial. Adv Ther. 2025 Sep;42(9):4335-4349. doi: 10.1007/s12325-025-03253-0. Epub 2025 Jun 23.
- Individual participant dataSharing planned: No
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)
59 sites in 2 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 Partial Seizures With or Without Secondary Generalization and Epilepsy, run by UCB Biopharma SRL at 59 sites in 2 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 4 inclusion and 8 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 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Japan, China. 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 29 Jul 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 Baseline until end of the safety follow up (up to 88.5 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03250377, which also lists 1 linked publication.
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 29 Jul 2025.