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 - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 12, 2008

Last Updated Date

April 1, 2009

Start Date ^†

August 2008

Current Primary Outcome Measures ^†

The primary efficacy analysis variable is the cumulative exit rate at 112 days after the beginning of the baseline AED tapering phase. [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00699283 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

An International, Double-Blind, Randomized, Multi-Center, Parallel Group, Historical-Control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization.

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 BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^†

Epilepsy

Intervention ^†

Drug: Brivaracetam

Study Arms / Comparison Groups

Experimental: 50mg daily
Experimental: 100mg daily

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

178

Estimated Completion Date

April 2011

Estimated Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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 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.

Gender

Both

Ages

16 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: UCB Clinical Trial Call Center

+1-877-822-9493

Location Countries ^†

United States, Finland, France, Germany, Hungary, Italy, Spain

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00699283

Responsible Party

Study Director, UCB

Secondary IDs ^††

RPCE07F1216

Study Sponsor ^†

UCB

Collaborators ^††

Investigators ^†

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

Information Provided By

UCB

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.