A Open Label Study of a Flexible Dose of Brivaracetam in Subjects 16 Years or Older Suffering From Epilepsy - Tabular View

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

Tracking Information

First Received Date ^†

September 6, 2005

Last Updated Date

April 20, 2009

Start Date ^†

January 2006

Current Primary Outcome Measures ^†

To evaluate the safety and efficacy of brivaracetam at individualized doses in subjects suffering from epilepsy. [ Time Frame: This long-term follow-up trial will run throughout the duration of the clinical development period of brivaracetam. It will end when approval of brivaracetam has been obtained in US or when the investigational product development has stopped. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00150800 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To evaluate the maintenance of efficacy over time. [ Time Frame: duration of the trial ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Open Label Study of a Flexible Dose of Brivaracetam in Subjects 16 Years or Older Suffering From Epilepsy

Official Title ^†

An Open-Label, Multicenter, Follow-up Trial to Evaluate Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 150 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of brivaracetam.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Epilepsy

Intervention ^†

Drug: Brivaracetam (ucb 34714)

Study Arms / Comparison Groups

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 ^†

Enrolling by invitation

Enrollment ^†

1000

Estimated Completion Date

January 2011

Estimated Primary Completion Date

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

Eligibility Criteria ^†

Inclusion Criteria:

Male/female subjects from 16 years or older.
Subjects with epilepsy who participated in previous brivaracetam trials
Subjects from whom the investigator believes a reasonable benefit from the long-term administration of brivaracetam may be expected

Exclusion Criteria:

Severe medical, neurological and psychiatric disorders or laboratory values which may have an impact on the safety of the subject.
Poor compliance with the visit schedule or medication intake in the previous brivaracetam trial

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Australia, Brazil, Canada, India, Mexico

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00150800

Responsible Party

Study Director, UCB

Secondary IDs ^††

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.