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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Partial Seizures With or Without Secondary Generalization, Epilepsy

Intervention / Treatment
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* Drug: Brivaracetam


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brivaracetam<br>Subjects randomized to this arm will receive open-label Brivaracetam | Drug: Brivaracetam<br>* Pharmaceutical form: Film-coated tablet Concentration: 25 mg and 50 mg Route of administration: Oral use<br>* Other names: Briviact;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of study participants with treatment-emergent adverse events (TEAEs) | 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. | From study entry until Final Visit (up to 70 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in partial seizure frequency per 28 days from Baseline of EP0083 or N01358 to the Evaluation Period | 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. | Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months) | 
| Responder rate in partial seizure frequency per 28 days over the Evaluation Period | 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. | Baseline of EP0083 or N01358 and by 3-month periods over the Evaluation Period (up to 70 months) | 
| 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 | A study participant was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period. | During the Evaluation Period (up to 70 months) | 
| 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 | A study participant was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period. | During the Evaluation Period (up to 70 months) | 
| Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period | A study participant was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period. | During the Evaluation Period (up to 70 months) | 
| Percent change in partial seizure frequency per 28 days from Baseline of directly enrolled study participants to the Evaluation Period | 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. | Baseline from 8 weeks prior to BRV administration over the Evaluation Period (up to 70 months) | 
| Responder rate in partial seizure frequency per 28 days over the Evaluation Period for directly enrolled study participants | 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. | Baseline from 8 weeks prior to BRV administration over the Evaluation Period (up to 70 months) | 
| 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 | A study participant was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period. | During the Evaluation Period (up to 70 months) | 
| 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 | A study participant was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period. | During the Evaluation Period (up to 70 months) | 
| Percentage of participants continuously seizure-free for partial seizure and all seizure types during the Evaluation Period for directly enrolled study particpants | A study participant was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period. | During the Evaluation Period (up to 70 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Briviact, Brivaracetam, Epilepsy, Partial seizures with or without secondary generalization