Last updated on July 2019

A Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam Subjects (>=16 to 80 Years of Age) With Epilepsy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Epilepsy | Partial Seizures With or Without Secondary Generalization
  • Age: Between 16 - 80 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive. Subjects who are not legal adults may only be included where legally permitted and ethically accepted
  • Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
  • Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification
  • Presence of an electroencephalogram (EEG) reading compatible with the clinical diagnosis of focal epilepsy within the last 5 years
  • Presence of a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan performed within the last 2 years
  • Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period
  • Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1
  • Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug [AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
  • Permitted concomitant AED(s) and VNS being stable and at optimal dosage for the subject from at least 4 weeks (12 weeks for phenobarbital, phenytoin, and primidone) before Visit 1 and expected to be kept stable during whole study period

Exclusion Criteria:

  • Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
  • Subject has history of cerebrovascular accident, including transient ischemic attack, in the last 24 weeks
  • Subject has history or presence of known psychogenic nonepileptic seizures

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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