A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Subjects (>=16 to 80 Years of Age) With Partial Seizures With or Without Secondary Generalization
1 other identifier
interventional
449
7 countries
94
Brief Summary
The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (\>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects \>= 16 years to 80 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2017
Longer than P75 for phase_3
94 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 20, 2017
CompletedStudy Start
First participant enrolled
August 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedResults Posted
Study results publicly available
November 9, 2023
CompletedOctober 14, 2025
September 1, 2025
4.9 years
February 28, 2017
December 15, 2022
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
An 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. Treatment-Emergent AEs were defined as AEs which had onset on or after the first dose of IMP. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)
Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal
An 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. Treatment-Emergent AEs were defined as AEs which had onset on or after the first dose of IMP. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)
Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Serious Adverse event (SAE) was defined as any events which: • results in death, • is life-threatening threatening (note that this did not include a reaction that might have caused death had it occurred in a more severe form.), •results in significant or persistent disability/incapacity, • results in a congenital anomaly/birth defect (including that occurring in a fetus), • results in Important medical event that, based upon appropriate medical judgment, may jeopardize the participant and might require medical or surgical intervention to prevent 1 of the other outcomes listed here, and • results in initial inpatient hospitalization or prolongation of hospitalization. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.
From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)
Partial Seizure Frequency Per 28 Days During the 12-week Treatment Period
According to International League Against Epilepsy (ILAE) classification (1981), seizures were classified as type IA (IA1, IA2, IA3, and IA4), IB, IC, II (IIA, IIB, IIC, IID, IIE, and IIF) or III. 28 day adjusted seizure frequency for partial seizures (seizure types IA+IB+IC) was calculated for treatment period by dividing the number of partial seizures by the number of days for which the DRC was completed for treatment period and multiplying the resulting value by 28.
From Baseline to 12-week Treatment Period
Secondary Outcomes (9)
50% Responder Rate Based on Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
From Baseline to 12-week Treatment Period
Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
From Baseline to 12-week Treatment Period
Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
From Baseline to 12-week Treatment Period
All Seizure Frequency (Partial, Generalized, and Unclassified Epileptic Seizures) Per 28 Days During the 12-week Treatment Period
During the 12-week Treatment Period
Percentage of Participants Who Are Seizure Free (Partial, All Epileptic Seizures) During the 12-week Treatment Period
During the 12-week Treatment Period
- +4 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATOR* 12 weeks Treatment Period: Subjects will receive Placebo * 4 weeks Down-Titration Period: Subjects will receive Placebo
BRV 50 mg/day
EXPERIMENTAL12 weeks Treatment Period: Subjects will receive BRV 50 mg/day \- Subjects entering into the Long term follow up (LTFU) study or managed access program (MAP): 2 weeks Transition Period: Subjects will receive BRV 50 mg/day followed by LTFU or MAP: Subjects will receive BRV 100 mg/day \- Subjects not entering into the LTFU study or MAP: 4 weeks Down-Titration Period: Subjects will receive BRV 25 mg/day for 1 week followed by Placebo for 3 weeks, followed by a Study Drug-Free Period
BRV 200 mg/day
EXPERIMENTAL12 weeks Treatment Period: Subjects will receive BRV 200 mg/day \- Subjects entering into the Long term follow up (LTFU) study or managed access program (MAP): 2 weeks Transition Period: Subjects will receive BRV 150 mg/day followed by LTFU or MAP: Subjects will receive BRV 100 mg/day \- Subjects not entering into the LTFU study or MAP: 4 weeks Down-Titration Period: Subjects will receive BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week followed by a Study Drug-Free Period
Interventions
* Pharmaceutical form: Film-coated tablets * Route of administration: Oral use
* Pharmaceutical form: Film-coated tablets * Concentration: 25 mg tablets and 50 mg tablets * Route of administration: Oral use
Eligibility Criteria
You may qualify if:
- Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive
- Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
- Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period
- Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1
- Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug \[AED\](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
You may not qualify if:
- Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
- Subject is currently treated with levetiracetam
- Subject has taken levetiracetam within 90 days prior to Visit 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
Ep0083 905
Beijing, China
Ep0083 906
Beijing, China
Ep0083 907
Changchun, China
Ep0083 901
Chengdu, China
Ep0083 902
Guangzhou, China
Ep0083 909
Guangzhou, China
Ep0083 917
Guangzhou, China
Ep0083 920
Guangzhou, China
Ep0083 922
Guangzhou, China
Ep0083 924
Guangzhou, China
Ep0083 912
Hangzhou, China
Ep0083 908
Lanzhou, China
Ep0083 921
Nanchang, China
Ep0083 926
Pingxiang, China
Ep0083 910
Shijiazhuang, China
Ep0083 925
Suzhou, China
Ep0083 913
Wenzhou, China
Ep0083 927
Xi'an, China
Ep0083 930
Xinxiang, China
Ep0083 916
Yinchuan, China
Ep0083 918
Zhanjiang, China
Ep0083 904
Zhengzhou, China
Ep0083 923
Zunyi, China
Ep0083 148
Adachi-ku, Japan
Ep0083 116
Asaka, Japan
Ep0083 126
Bunkyō City, Japan
Ep0083 127
Bunkyō City, Japan
Ep0083 146
Chiba, Japan
Ep0083 122
Hachinohe, Japan
Ep0083 111
Hamamatsu, Japan
Ep0083 141
Higashisonogi-gun Kawatana-cho, Japan
Ep0083 110
Hiroshima, Japan
Ep0083 121
Itami, Japan
Ep0083 102
Kagoshima, Japan
Ep0083 142
Kamakura, Japan
Ep0083 140
Kawasaki, Japan
Ep0083 123
Kodaira, Japan
Ep0083 115
Kokubunji, Japan
Ep0083 132
Kōriyama, Japan
Ep0083 112
Kōshi, Japan
Ep0083 128
Kurume, Japan
Ep0083 124
Kyoto, Japan
Ep0083 147
Kyoto, Japan
Ep0083 105
Nagakute, Japan
Ep0083 118
Nagoya, Japan
Ep0083 136
Nagoya, Japan
Ep0083 117
Nara, Japan
Ep0083 129
Neyagawa, Japan
Ep0083 106
Niigata, Japan
Ep0083 130
Ôsaka, Japan
Ep0083 131
Ōtsu, Japan
Ep0083 114
Saitama, Japan
Ep0083 101
Sapporo, Japan
Ep0083 103
Sendai, Japan
Ep0083 144
Shinjuku-ku, Japan
Ep0083 104
Shizuoka, Japan
Ep0083 108
Suita, Japan
Ep0083 137
Suita, Japan
Ep0083 138
Tsukuba, Japan
Ep0083 133
Ushiku, Japan
Ep0083 109
Yamagata, Japan
Ep0083 120
Yokohama, Japan
Ep0083 150
Yokohama, Japan
Ep0083 207
Kota Bharu, Malaysia
Ep0083 201
Kuala Lumpur, Malaysia
Ep0083 206
Kuala Terengganu, Malaysia
Ep0083 204
Kuching, Malaysia
Ep0083 209
Miri, Malaysia
Ep0083 202
Perai, Malaysia
Ep0083 208
Pulau Pinang, Malaysia
Ep0083 203
Sungai Buloh, Malaysia
Ep0083 303
Cebu City, Philippines
Ep0083 304
Cebu City, Philippines
Ep0083 306
Davao City, Philippines
Ep0083 307
Iloilo City, Philippines
Ep0083 301
Manila, Philippines
Ep0083 302
Manila, Philippines
Ep0083 310
Manila, Philippines
Ep0083 309
Quezon City, Philippines
Ep0083 401
Singapore, Singapore
Ep0083 402
Singapore, Singapore
Ep0083 502
Chiayi City, Taiwan
Ep0083 505
Kaohsiung City, Taiwan
Ep0083 503
Taichung, Taiwan
Ep0083 504
Taichung, Taiwan
Ep0083 501
Tainan, Taiwan
Ep0083 602
Bangkok, Thailand
Ep0083 605
Bangkok, Thailand
Ep0083 606
Bangkok, Thailand
Ep0083 607
Bangkok, Thailand
Ep0083 609
Bangkok, Thailand
Ep0083 601
Khon Kaen, Thailand
Ep0083 603
Muang, Thailand
Ep0083 608
Muang, Thailand
Related Publications (1)
Usui N, Zhou D, Qin B, Tiamkao S, Cabral-Lim L, Lim KS, Lim SH, Tsai JJ, Watanabe J, Sun W, Dickson N, Moseley B, Bourikas D, Inoue Y. Temporal Profile of Treatment-Emergent Adverse Events in Adult Asian Patients with Focal-Onset Seizures During Adjunctive Brivaracetam Treatment: Post Hoc Analysis of a Phase 3, Randomized Trial. Adv Ther. 2025 Nov;42(11):5639-5652. doi: 10.1007/s12325-025-03357-7. Epub 2025 Sep 13.
PMID: 40944847RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 20, 2017
Study Start
August 22, 2017
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
October 14, 2025
Results First Posted
November 9, 2023
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.