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
NCT ID: NCT03250377
Last Updated: 2025-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
207 participants
INTERVENTIONAL
2017-08-05
2024-12-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brivaracetam
Subjects randomized to this arm will receive open-label Brivaracetam
Brivaracetam
* Pharmaceutical form: Film-coated tablet
* Concentration: 25 mg and 50 mg
* Route of administration: Oral use
Interventions
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Brivaracetam
* Pharmaceutical form: Film-coated tablet
* Concentration: 25 mg and 50 mg
* Route of administration: Oral use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
16 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
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Ep0085 905
Beijing, , China
Ep0085 901
Chengdu, , China
Ep0085 902
Guangzhou, , China
Ep0085 909
Guangzhou, , China
Ep0085 917
Guangzhou, , China
Ep0085 920
Guangzhou, , China
Ep0085 924
Guangzhou, , China
Ep0085 912
Hangzhou, , China
Ep0085 908
Lanzhou, , China
Ep0085 921
Nanchang, , China
Ep0085 926
Pingxiang, , China
Ep0085 910
Shijiazhuang, , China
Ep0085 925
Suzhou, , China
Ep0085 913
Wenzhou, , China
Ep0085 930
Xinxiang, , China
Ep0085 916
Yinchuan, , China
Ep0085 918
Zhanjiang, , China
Ep0085 904
Zhengzhou, , China
Ep0085 923
Zunyi, , China
Ep0085 148
Adachi-ku, , Japan
Ep0085 116
Asaka, , Japan
Ep0085 126
Bunkyō City, , Japan
Ep0085 127
Bunkyō City, , Japan
Ep0085 122
Hachinohe, , Japan
Ep0085 111
Hamamatsu, , Japan
Ep0085 141
Higashisonogi-gun Kawatana-cho, , Japan
Ep0085 110
Hiroshima, , Japan
Ep0085 121
Itami, , Japan
Ep0085 102
Kagoshima, , Japan
Ep0085 142
Kamakura, , Japan
Ep0085 140
Kawasaki, , Japan
Ep0085 123
Kodaira, , Japan
Ep0085 115
Kokubunji, , Japan
Ep0085 132
Kōriyama, , Japan
Ep0085 112
Kōshi, , Japan
Ep0085 128
Kurume, , Japan
Ep0085 124
Kyoto, , Japan
Ep0085 147
Kyoto, , Japan
Ep0085 105
Nagakute, , Japan
Ep0085 118
Nagoya, , Japan
Ep0085 136
Nagoya, , Japan
Ep0085 117
Nara, , Japan
Ep0085 129
Neyagawa, , Japan
Ep0085 106
Niigata, , Japan
Ep0085 850
Osaka, , Japan
Ep0085 130
Ôsaka, , Japan
Ep0085 131
Ōtsu, , Japan
Ep0085 114
Saitama, , Japan
Ep0085 101
Sapporo, , Japan
Ep0085 103
Sendai, , Japan
Ep0085 144
Shinjuku-ku, , Japan
Ep0085 104
Shizuoka, , Japan
Ep0085 108
Suita, , Japan
Ep0085 137
Suita, , Japan
Ep0085 138
Tsukuba, , Japan
Ep0085 133
Ushiku, , Japan
Ep0085 109
Yamagata, , Japan
Ep0085 120
Yokohama, , Japan
Ep0085 150
Yokohama, , Japan
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EP0085
Identifier Type: -
Identifier Source: org_study_id
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