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

UCB

Status and phase: Completed; Phase 3

Conditions: Partial Seizures With or Without Secondary Generalization; Epilepsy

Treatments: Drug: Placebo; Drug: Brivaracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT03083665

EP0083

Details and patient eligibility

About

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.

Enrollment: 449 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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449 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

* 12 weeks Treatment Period: Subjects will receive Placebo * 4 weeks Down-Titration Period: Subjects will receive Placebo

Treatment:

Drug: Placebo

BRV 50 mg/day

Experimental group

Description:

12 weeks Treatment Period: Subjects will receive BRV 50 mg/day - Subjects entering into the Long term follow up (LTFU) study or managed access program (MAP): 2 weeks Transition Period: Subjects will receive BRV 50 mg/day followed by LTFU or MAP: Subjects will receive BRV 100 mg/day - Subjects not entering into the LTFU study or MAP: 4 weeks Down-Titration Period: Subjects will receive BRV 25 mg/day for 1 week followed by Placebo for 3 weeks, followed by a Study Drug-Free Period

Treatment:

Drug: Brivaracetam

Drug: Placebo

BRV 200 mg/day

Experimental group

Description:

12 weeks Treatment Period: Subjects will receive BRV 200 mg/day - Subjects entering into the Long term follow up (LTFU) study or managed access program (MAP): 2 weeks Transition Period: Subjects will receive BRV 150 mg/day followed by LTFU or MAP: Subjects will receive BRV 100 mg/day - Subjects not entering into the LTFU study or MAP: 4 weeks Down-Titration Period: Subjects will receive BRV 150 mg/day for 1 week followed by BRV 100 mg/day for 1 week, followed by BRV 50 mg/day for 1 week, followed by BRV 25 mg/day for 1 week followed by a Study Drug-Free Period

Treatment:

Drug: Brivaracetam

Drug: Placebo