Clinical trial NCT03250377: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Partial Seizures With or Without Secondary Generalization
Epilepsy
Keywords: Brivaracetam
Epilepsy
Partial seizures with or without secondary generalization
Briviact
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 207
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Percentage of study participants with treatment-emergent adverse events (TEAEs)
timeFrame: From study entry until Final Visit (up to 70 months)
Secondary outcomes:
measure: Percent change in partial seizure frequency per 28 days from Baseline of EP0083 or N01358 to the Evaluation Period
timeFrame: Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months)
measure: Responder rate in partial seizure frequency per 28 days over the Evaluation Period
timeFrame: Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months)
measure: 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
timeFrame: During the Evaluation Period (up to 70 months)
measure: 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
timeFrame: During the Evaluation Period (up to 70 months)
measure: Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period
timeFrame: During the Evaluation Period (up to 70 months)
measure: Percent change in partial seizure frequency per 28 days from Baseline of directly enrolled study participants to the Evaluation Period
timeFrame: Baseline from 8 weeks prior to BRV administration over the Evaluation Period (up to 70 months)
measure: Responder rate in partial seizure frequency per 28 days over the Evaluation Period for directly enrolled study participants
timeFrame: Baseline from 8 weeks prior to BRV administration over the Evaluation Period (up to 70 months)
measure: 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 particpants
timeFrame: During the Evaluation Period (up to 70 months)
measure: 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 particpants
timeFrame: During the Evaluation Period (up to 70 months)
measure: Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period for directly enrolled study particpants
timeFrame: During the Evaluation Period (up to 70 months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Ep0085 905
city: Chengdu
country: China
facility: Ep0085 901
city: Guangzhou
country: China
facility: Ep0085 902
city: Guangzhou
country: China
facility: Ep0085 909
city: Guangzhou
country: China
facility: Ep0085 917
city: Guangzhou
country: China
facility: Ep0085 920
city: Guangzhou
country: China
facility: Ep0085 924
city: Hangzhou
country: China
facility: Ep0085 912
city: Lanzhou
country: China
facility: Ep0085 908
city: Nanchang
country: China
facility: Ep0085 921
city: Pingxiang
country: China
facility: Ep0085 926
city: Shijiazhuang
country: China
facility: Ep0085 910
city: Suzhou
country: China
facility: Ep0085 925
city: Wenzhou
country: China
facility: Ep0085 913
city: Xinxiang
country: China
facility: Ep0085 930
city: Yinchuan
country: China
facility: Ep0085 916
city: Zhanjiang
country: China
facility: Ep0085 918
city: Zhengzhou
country: China
facility: Ep0085 904
city: Zunyi
country: China
facility: Ep0085 923
city: Adachi-ku
country: Japan
facility: Ep0085 148
city: Asaka
country: Japan
facility: Ep0085 116
city: Bunkyo-ku
country: Japan
facility: Ep0085 126
city: Bunkyo-ku
country: Japan
facility: Ep0085 127
city: Hachinohe
country: Japan
facility: Ep0085 122
city: Hamamatsu
country: Japan
facility: Ep0085 111
city: Higashisonogi-gun Kawatana-cho
country: Japan
facility: Ep0085 141
city: Hiroshima-shi
country: Japan
facility: Ep0085 110
city: Itami
country: Japan
facility: Ep0085 121
city: Kagoshima
country: Japan
facility: Ep0085 102
city: Kamakura
country: Japan
facility: Ep0085 142
city: Kawasaki
country: Japan
facility: Ep0085 140
city: Kodaira
country: Japan
facility: Ep0085 123
city: Kokubunji
country: Japan
facility: Ep0085 115
city: Koriyama
country: Japan
facility: Ep0085 132
city: Koshi
country: Japan
facility: Ep0085 112
city: Kurume
country: Japan
facility: Ep0085 128
city: Kyoto
country: Japan
facility: Ep0085 124
city: Kyoto
country: Japan
facility: Ep0085 147
city: Nagakute
country: Japan
facility: Ep0085 105
city: Nagoya
country: Japan
facility: Ep0085 118
city: Nagoya
country: Japan
facility: Ep0085 136
city: Nara
country: Japan
facility: Ep0085 117
city: Neyagawa
country: Japan
facility: Ep0085 129
city: Niigata
country: Japan
facility: Ep0085 106
city: Osaka
country: Japan
facility: Ep0085 850
city: Otsu
country: Japan
facility: Ep0085 131
city: Saitama
country: Japan
facility: Ep0085 114
city: Sapporo
country: Japan
facility: Ep0085 101
city: Sendai
country: Japan
facility: Ep0085 103
city: Shinjuku-ku
country: Japan
facility: Ep0085 144
city: Shizuoka
country: Japan
facility: Ep0085 104
city: Suita
country: Japan
facility: Ep0085 108
city: Suita
country: Japan
facility: Ep0085 137
city: Tsukuba
country: Japan
facility: Ep0085 138
city: Ushiku
country: Japan
facility: Ep0085 133
city: Yamagata
country: Japan
facility: Ep0085 109
city: Yokohama
country: Japan
facility: Ep0085 120
city: Yokohama
country: Japan
facility: Ep0085 150
city: Ôsaka
country: Japan
facility: Ep0085 130
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: