This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment

Study Overview
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Brief Summary
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This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.

Detailed Description
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Study access was limited to subjects having completed one of the previous brivaracetam (BRV) studies: N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881].

Official Title
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An Open-label, Multi-center, Follow-up Trial to Evaluate Long Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment 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: Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted Subjects with epilepsy who have participated in previous brivaracetam trials which allow access to the present study Subjects for whom the investigator believes a reasonable benefit from the long term administration of brivaracetam may be expected Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator Exclusion Criteria: Severe medical, neurological and psychiatric disorders or laboratory values which may have an impact on the safety of the subject Poor compliance with the visit schedule or medication intake in the previous brivaracetam study Pregnant or lactating women Participation in any clinical study of another investigational drug or device during the study

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 used as adjunctive treatment, flexible dosing up to 200 mg /day in b.i.d (twice daily) administration. Dose increase or decrease can be made in increments of maximum 50 mg/day on a weekly basis. | Drug: Brivaracetam<br>* Active Substance: Brivaracetam Pharmaceutical Form: Tablet Concentration: 10 mg and 25 mg Route of Administration: Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period | Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment. | Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) | 
| Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period | Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment. | Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) | 
| Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period | A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose. | Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period | Baseline is the Baseline from subject's previous study of enrollment period. N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254 [NCT00504881]. A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28. | From Baseline of the previous study to the Evaluation Period (up to 11 years) | 
| Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period | The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as: (the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines. | From Baseline of the previous study to the Evaluation Period (up to 11 years) | 
| Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period | A responder is defined as a subject with a higher than or equal to (>=) 50 % change in seizure frequency from Baseline period of the previous study. | From Baseline of the previous study to the Evaluation Period (up to 11 years) | 

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