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
- Conditions
- Partial Seizures With or Without Secondary GeneralizationEpilepsy
- Interventions
- Registration Number
- NCT03250377
- Lead Sponsor
- UCB Biopharma SRL
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brivaracetam Brivaracetam Subjects randomized to this arm will receive open-label Brivaracetam
- Primary Outcome Measures
Name Time Method Percentage of study participants with treatment-emergent adverse events (TEAEs) From study entry until Final Visit (up to 70 months) An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method Percent change in partial seizure frequency per 28 days from Baseline of EP0083 or N01358 to the Evaluation Period Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months) The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months of the Evaluation Period (by 3-month periods). Change in seizure frequency from Baseline of EP0083 (NCT03083665) or N01358 (NCT01261325) is calculated as the seizure frequency at the evaluation time point minus the seizure frequency at Baseline of EP0083 or N01358.
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 During the Evaluation Period (up to 70 months) A study participant was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period.
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 During the Evaluation Period (up to 70 months) A study participant was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period.
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 During the Evaluation Period (up to 70 months) A study participant was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period.
Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period for directly enrolled study particpants During the Evaluation Period (up to 70 months) A study participant was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period.
Responder rate in partial seizure frequency per 28 days over the Evaluation Period Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months) The seizure frequency is calculated as number of seizures per 28 days. This evaluation will be done every 3 months of the Evaluation Period (by 3-month periods). A responder is defined as a subject with a \>= 50% reduction in seizure frequency from the Baseline Period of EP0083 or N01358.
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 During the Evaluation Period (up to 70 months) A study participant was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period.
Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period During the Evaluation Period (up to 70 months) A study participant was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period.
Percent change in partial seizure frequency per 28 days from Baseline of directly enrolled study participants to the Evaluation Period Baseline from 8 weeks prior to BRV administration over the Evaluation Period (up to 70 months) The seizure frequency for directly enrolled participants is calculated as number of seizures per 28 days from 8 weeks prior to BRV administration.
Change in seizure frequency is calculated as the seizure frequency at the evaluation time point minus the seizure frequency at Baseline of directly enrolled participants.Responder rate in partial seizure frequency per 28 days over the Evaluation Period for directly enrolled study participants Baseline from 8 weeks prior to BRV administration over the Evaluation Period (up to 70 months) The seizure frequency for directly enrolled participants is calculated as number of seizures per 28 days from 8 weeks prior to BRV administration.
A responder is defined as a study participant with a \>= 50% reduction in seizure frequency from the Baseline Period.
Trial Locations
- Locations (59)
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 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
🇯🇵Bunkyo-ku, Japan
Ep0085 127
🇯🇵Bunkyo-ku, Japan
Ep0085 122
🇯🇵Hachinohe, Japan
Ep0085 111
🇯🇵Hamamatsu, Japan
Ep0085 141
🇯🇵Higashisonogi-gun Kawatana-cho, Japan
Ep0085 110
🇯🇵Hiroshima-shi, 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
🇯🇵Koriyama, Japan
Ep0085 112
🇯🇵Koshi, 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 926
🇨🇳Pingxiang, China
Ep0085 910
🇨🇳Shijiazhuang, China
Ep0085 925
🇨🇳Suzhou, China
Ep0085 117
🇯🇵Nara, Japan
Ep0085 131
🇯🇵Otsu, Japan
Ep0085 114
🇯🇵Saitama, Japan
Ep0085 101
🇯🇵Sapporo, Japan
Ep0085 129
🇯🇵Neyagawa, Japan
Ep0085 106
🇯🇵Niigata, Japan
Ep0085 850
🇯🇵Osaka, 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
Ep0085 130
🇯🇵Ôsaka, Japan