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

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma S.P.R.L.; UCB Biopharma SRL
• Treatments: Brivaracetam

Criteria

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