A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

Phase 3

Terminated

• Conditions: Epilepsy
• Interventions: Drug: Brivaracetam

• Registration Number: NCT00698581
• Lead Sponsor: UCB Pharma

Brief Summary

Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-17
• Study Start: 2008-08
• Primary Completion: 2010-01
• Study Completion: 2010-02
• Disposition First Submitted: 2011-02-09
• Disposition First Submitted QC: 2011-02-09
• Disposition First Posted: 2011-02-11
• Results First Submitted: 2016-03-14
• Results First Submitted QC: 2016-03-14
• Results First Posted: 2016-04-13
• Status Verified: 2018-03
• Last Update Submitted: 2018-06-13
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Subjects from 16 to 75 years, both inclusive
• Well-characterized focal epilepsy or epileptic syndrome
• Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period
• Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50 % of the minimum recommended maintenance dose

Exclusion Criteria

• Seizure type IA non-motor as only seizure type
• History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline
• Other serious uncontrolled disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brivaracetam 100 mg	Brivaracetam	100 mg/day
Brivaracetam 50 mg	Brivaracetam	50 mg/day

Primary Outcome Measures

Name	Time	Method
The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase	From Week 1 up to Week 17	The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.

Secondary Outcome Measures

Name	Time	Method
The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study	Baseline through Re-conversion (approximately 31 weeks)
The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study	Baseline through Re-conversion (approximately 31 weeks)
The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study	Baseline through Re-conversion (approximately 31 weeks)