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

  • End date
    Jul 16, 2022
  • participants needed
  • sponsor
    UCB Biopharma SRL
Updated on 16 July 2021
adjunctive treatment
vagus nerve stimulation
partial seizure


The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects >= 16 years to 80 years of age.

Condition Epilepsy, Seizure Disorders (Pediatric), Partial Seizures With or Without Secondary Generalization, Seizure Disorders, epileptic, seizure disorder, epilepsia, epileptics
Treatment Placebo, Brivaracetam
Clinical Study IdentifierNCT03083665
SponsorUCB Biopharma SRL
Last Modified on16 July 2021


Yes No Not Sure

Inclusion Criteria

Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive
Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
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

Exclusion Criteria

Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
Subject is currently treated with levetiracetam
Subject has taken levetiracetam within 90 days prior to Visit 1
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