Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

• Responder rate for partial onset seizures (Type I) frequency per week over the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  Responder rate for partial onset seizures (Type I) frequency per week over the 12-week Treatment Period
• All seizure frequency (Type I+II+III) per week over the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  All seizure frequency (Type I+II+III) per week over the 12-week Treatment Period
• Percent change from Baseline to the 12-week Treatment Period in partial onset seizure (Type I) frequency per week [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  Percent change from Baseline to the 12-week Treatment Period in partial onset seizure (Type I) frequency per week
• Categorized percentage change from Baseline in seizure frequency for partial onset seizure (Type I)over the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  Categorized percentage change from Baseline in seizure frequency for partial onset seizure (Type I) over the 12-week Treatment Period
• Seizure freedom rate (all seizure types) over the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  Seizure freedom rate (all seizure types) over the 12-week Treatment Period
• Time to first Type I seizure during the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  Time to first Type I seizure during the 12-week Treatment Period
• Time to fifth Type I seizure during the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  Time to fifth Type I seizure during the 12-week Treatment Period
• Time to tenth Type I seizure during the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  Time to tenth Type I seizure during the 12-week Treatment Period
• Reduction of Type IC/Type I seizure frequency ratio from Baseline to the 12- week Treatment Period. [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  Reduction of Type IC/Type I seizure frequency ratio from Baseline to the 12- week Treatment Period.
• Change from Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  Change from Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score
• Change from Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  Change from Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score
• Change from Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  Change from Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score
• Change from Baseline to the 12-week Treatment Period in Hospital Anxiety score [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  Change from Baseline to the 12-week Treatment Period in Hospital Anxiety score
• Change from Baseline to the 12-week Treatment Period in Hospital Depression score [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]
  Change from Baseline to the 12-week Treatment Period in Hospital Depression score
• Patient's Global Evaluation Scale (P-GES) evaluated at last visit or early discontinuation visit [ Time Frame: Baseline to last visit or early discontinuation visit in the 12-week Treatment Period ] [ Designated as safety issue: No ]
  Patient's Global Evaluation Scale (P-GES) evaluated at last visit or early discontinuation visit
• Investigator's Global Evaluation Scale (I-GES) evaluated at last visit or early discontinuation visit [ Time Frame: Baseline to last visit or early discontinuation visit in the 12-week Treatment Period ] [ Designated as safety issue: No ]
  Investigator's Global Evaluation Scale (I-GES) evaluated at last visit or early discontinuation visit

This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.

• Other: Placebo
  Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period
• Drug: Brivaracetam
  Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period
• Drug: Brivaracetam
  Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day in a double-blinded way for the 12-week Treatment Period.
• Drug: Brivaracetam
  Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 100 mg /day in a double-blinded way for the 12-week Treatment Period.

• Placebo Comparator: Placebo
  Matching Placebo tablets administered twice a day
  Intervention: Other: Placebo
• Experimental: Brivaracetam 20 mg/day
  Brivaracetam 20 mg/day, 10 mg administered twice a day
  Intervention: Drug: Brivaracetam
• Experimental: Brivaracetam 50 mg/day
  Brivaracetam 50 mg/day, 25 mg administered twice a day
  Intervention: Drug: Brivaracetam
• Experimental: Brivaracetam 100 mg/day
  Brivaracetam 100 mg/day, 50 mg administered twice a day
  Intervention: Drug: Brivaracetam

Inclusion Criteria:

• Subjects were from 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
• Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
• Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)
• Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1
• Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period
• Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED

Exclusion Criteria:

• History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3
• History or presence of status epilepticus during the year preceding Visit 1 or during Baseline