Clinical trial NCT03083665: A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Seizures With or Without Secondary Generalization
Epilepsy
Keywords: Epilepsy
Partial seizures with or without secondary generalization
Brivaracetam
Briviact
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-03-20
Enrollment: 449
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: 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)
measure: Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal
timeFrame: 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)
measure: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
timeFrame: 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)
measure: Partial Seizure Frequency Per 28 Days During the 12-week Treatment Period
timeFrame: From Baseline to 12-week Treatment Period
Secondary outcomes:
measure: 50% Responder Rate Based on Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
timeFrame: From Baseline to 12-week Treatment Period
measure: Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
timeFrame: From Baseline to 12-week Treatment Period
measure: Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period
timeFrame: From Baseline to 12-week Treatment Period
measure: All Seizure Frequency (Partial, Generalized, and Unclassified Epileptic Seizures) Per 28 Days During the 12-week Treatment Period
timeFrame: During the 12-week Treatment Period
measure: Percentage of Participants Who Are Seizure Free (Partial, All Epileptic Seizures) During the 12-week Treatment Period
timeFrame: During the 12-week Treatment Period
measure: Time to 1st Partial Seizure During the 12-week Treatment Period
timeFrame: During the 12-week Treatment Period
measure: Time to 5th Partial Seizure During the 12-week Treatment Period
timeFrame: During the 12-week Treatment Period
measure: Time to 10th Partial Seizure During the 12-week Treatment Period
timeFrame: During the 12-week Treatment Period
measure: Brivaracetam Plasma Concentration
timeFrame: Plasma samples were collected at >0-4hours, >4-8hours, >8hours in weeks 2, 4, 8, 12, and 14
Other outcomes:
Locations:
city: Beijing
country: China
facility: Ep0083 905
city: Beijing
country: China
facility: Ep0083 906
city: Changchun
country: China
facility: Ep0083 907
city: Chengdu
country: China
facility: Ep0083 901
city: Guangzhou
country: China
facility: Ep0083 902
city: Guangzhou
country: China
facility: Ep0083 909
city: Guangzhou
country: China
facility: Ep0083 917
city: Guangzhou
country: China
facility: Ep0083 920
city: Guangzhou
country: China
facility: Ep0083 922
city: Guangzhou
country: China
facility: Ep0083 924
city: Hangzhou
country: China
facility: Ep0083 912
city: Lanzhou
country: China
facility: Ep0083 908
city: Nanchang
country: China
facility: Ep0083 921
city: Pingxiang
country: China
facility: Ep0083 926
city: Shijiazhuang
country: China
facility: Ep0083 910
city: Suzhou
country: China
facility: Ep0083 925
city: Wenzhou
country: China
facility: Ep0083 913
city: Xi'an
country: China
facility: Ep0083 927
city: Xinxiang
country: China
facility: Ep0083 930
city: Yinchuan
country: China
facility: Ep0083 916
city: Zhanjiang
country: China
facility: Ep0083 918
city: Zhengzhou
country: China
facility: Ep0083 904
city: Zunyi
country: China
facility: Ep0083 923
city: Adachi-ku
country: Japan
facility: Ep0083 148
city: Asaka
country: Japan
facility: Ep0083 116
city: Bunkyo-ku
country: Japan
facility: Ep0083 126
city: Bunkyo-ku
country: Japan
facility: Ep0083 127
city: Chiba-shi
country: Japan
facility: Ep0083 146
city: Hachinohe
country: Japan
facility: Ep0083 122
city: Hamamatsu
country: Japan
facility: Ep0083 111
city: Higashisonogi-gun Kawatana-cho
country: Japan
facility: Ep0083 141
city: Hiroshima
country: Japan
facility: Ep0083 110
city: Itami
country: Japan
facility: Ep0083 121
city: Kagoshima
country: Japan
facility: Ep0083 102
city: Kamakura
country: Japan
facility: Ep0083 142
city: Kawasaki
country: Japan
facility: Ep0083 140
city: Kodaira
country: Japan
facility: Ep0083 123
city: Kokubunji
country: Japan
facility: Ep0083 115
city: Koriyama
country: Japan
facility: Ep0083 132
city: Koshi
country: Japan
facility: Ep0083 112
city: Kurume
country: Japan
facility: Ep0083 128
city: Kyoto
country: Japan
facility: Ep0083 124
city: Kyoto
country: Japan
facility: Ep0083 147
city: Nagakute
country: Japan
facility: Ep0083 105
city: Nagoya
country: Japan
facility: Ep0083 118
city: Nagoya
country: Japan
facility: Ep0083 136
city: Nara
country: Japan
facility: Ep0083 117
city: Neyagawa
country: Japan
facility: Ep0083 129
city: Niigata
country: Japan
facility: Ep0083 106
city: Saitama
country: Japan
facility: Ep0083 114
city: Sapporo
country: Japan
facility: Ep0083 101
city: Sendai
country: Japan
facility: Ep0083 103
city: Shinjuku-ku
country: Japan
facility: Ep0083 144
city: Shizuoka
country: Japan
facility: Ep0083 104
city: Suita
country: Japan
facility: Ep0083 108
city: Suita
country: Japan
facility: Ep0083 137
city: Tsukuba
country: Japan
facility: Ep0083 138
city: Ushiku
country: Japan
facility: Ep0083 133
city: Yamagata
country: Japan
facility: Ep0083 109
city: Yokohama
country: Japan
facility: Ep0083 120
city: Yokohama
country: Japan
facility: Ep0083 150
city: Ôsaka
country: Japan
facility: Ep0083 130
city: Ōtsu
country: Japan
facility: Ep0083 131
city: Kota Bharu
country: Malaysia
facility: Ep0083 207
city: Kuala Lumpur
country: Malaysia
facility: Ep0083 201
city: Kuala Terengganu
country: Malaysia
facility: Ep0083 206
city: Kuching
country: Malaysia
facility: Ep0083 204
city: Miri
country: Malaysia
facility: Ep0083 209
city: Perai
country: Malaysia
facility: Ep0083 202
city: Pulau Pinang
country: Malaysia
facility: Ep0083 208
city: Sungai Buloh
country: Malaysia
facility: Ep0083 203
city: Cebu City
country: Philippines
facility: Ep0083 303
city: Cebu City
country: Philippines
facility: Ep0083 304
city: Davao City
country: Philippines
facility: Ep0083 306
city: Iloilo City
country: Philippines
facility: Ep0083 307
city: Manila
country: Philippines
facility: Ep0083 301
city: Manila
country: Philippines
facility: Ep0083 302
city: Manila
country: Philippines
facility: Ep0083 310
city: Quezon City
country: Philippines
facility: Ep0083 309
city: Singapore
country: Singapore
facility: Ep0083 401
city: Singapore
country: Singapore
facility: Ep0083 402
city: Chiayi City
country: Taiwan
facility: Ep0083 502
city: Kaohsiung
country: Taiwan
facility: Ep0083 505
city: Taichung City
country: Taiwan
facility: Ep0083 504
city: Taichung
country: Taiwan
facility: Ep0083 503
city: Tainan
country: Taiwan
facility: Ep0083 501
city: Bangkok
country: Thailand
facility: Ep0083 602
city: Bangkok
country: Thailand
facility: Ep0083 605
city: Bangkok
country: Thailand
facility: Ep0083 606
city: Bangkok
country: Thailand
facility: Ep0083 607
city: Bangkok
country: Thailand
facility: Ep0083 609
city: Khon Kaen
country: Thailand
facility: Ep0083 601
city: Muang
country: Thailand
facility: Ep0083 603
city: Muang
country: Thailand
facility: Ep0083 608
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: