A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
NCT ID: NCT03083665
Last Updated: 2025-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
449 participants
INTERVENTIONAL
2017-08-22
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
* 12 weeks Treatment Period: Subjects will receive Placebo
* 4 weeks Down-Titration Period: Subjects will receive Placebo
Placebo
* Pharmaceutical form: Film-coated tablets
* Route of administration: Oral use
BRV 50 mg/day
12 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
Placebo
* Pharmaceutical form: Film-coated tablets
* Route of administration: Oral use
Brivaracetam
* Pharmaceutical form: Film-coated tablets
* Concentration: 25 mg tablets and 50 mg tablets
* Route of administration: Oral use
BRV 200 mg/day
12 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
Placebo
* Pharmaceutical form: Film-coated tablets
* Route of administration: Oral use
Brivaracetam
* Pharmaceutical form: Film-coated tablets
* Concentration: 25 mg tablets and 50 mg tablets
* Route of administration: Oral use
Interventions
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Placebo
* Pharmaceutical form: Film-coated tablets
* Route of administration: Oral use
Brivaracetam
* Pharmaceutical form: Film-coated tablets
* Concentration: 25 mg tablets and 50 mg tablets
* Route of administration: Oral use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Subject is currently treated with levetiracetam
* Subject has taken levetiracetam within 90 days prior to Visit 1
16 Years
80 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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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 City, , 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
Countries
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References
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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 Sep 13. doi: 10.1007/s12325-025-03357-7. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EP0083
Identifier Type: -
Identifier Source: org_study_id
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