Long Term Follow-up Study With Levetiracetam XR (Keppra XR) for Partial Seizures - Tabular View

Tracking Information

First Received Date ^ICMJE

January 4, 2007

Last Updated Date

September 18, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary endpoint is the evaluation of the long-term safety of Keppra XR in patients with partial onset seizures. [ Time Frame: 2 - 3 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Safety

Change History

Complete list of historical versions of study NCT00419393 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

The following efficacy variables will be summarized descriptively: Percentage reduction for partial and total seizures; absolute reduction for partial onset and total seizures; cumulative proportion of subjects remained on Keppra XR monotherapy;
and seizure free day.

Descriptive Information

Brief Title ^ICMJE

Long Term Follow-up Study With Levetiracetam XR (Keppra XR) for Partial Seizures

Official Title ^ICMJE

An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures

Brief Summary

To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in patients with partial onset seizures.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: Levetiracetam XR

Study Arms / Comparison Groups

Experimental: 1000 - 3000 mg/day Keppra XR (Levetiracetam XR)

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 ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

190

Estimated Completion Date

April 2010

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects who were randomized into study N01280 and completed the 2-week up titration period

Exclusion Criteria:

Subjects who did not meet the inclusion/exclusion criteria for N01280.
Subjects who were discontinued prior to the end of titration period.

Gender

Both

Ages

12 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Mexico, Poland, Russian Federation

Administrative Information

NCT ID ^ICMJE

NCT00419393

Responsible Party

Study Director, UCB

Study ID Numbers ^ICMJE

N01281

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center, MD

+1 877 822 9493 (UCB)

Information Provided By

UCB, Inc.

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP