An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam

Study Overview
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Brief Summary
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The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.

Official Title
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An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy.

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Brivaracetam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with epilepsy who participated in previous brivaracetam trials which allow access to the present trial. Subjects from whom the Investigator believes a reasonable potential benefit from the long-term administration of brivaracetam may be expected. Exclusion Criteria: • Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behaviour, or laboratory values which may have an impact on the safety of the subject, as determined by the investigator.

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>Brivaracetam at flexible dosing up to 200mg /day | Drug: Brivaracetam<br>* Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths.<br>* Other names: ucb 34714;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) | Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment. | During the Evaluation Period (up to 9 years) | 
| Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) | Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment. | During the Evaluation Period (up to 9 years) | 
| Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) | An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. | During the Evaluation Period (up to 9 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years) | BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week. | During the Evaluation Period (up to 9 years) | 
| Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years) | BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week. | During the Evaluation Period (up to 9 years) | 
| Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years) | BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week. | During the Evaluation Period (up to 9 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Monotherapy, Partial Onset Seizures