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

Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Levetiracetam XR (Drug)

Phase: Phase 3

Status: Enrolling by invitation

Sponsored by: UCB

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, MD, Study Director, Affiliation: +1 877 822 9493 (UCB)

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.

Clinical Details

Official title: An Open-Label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-Onset Seizures

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

Primary outcome: The primary endpoint is the evaluation of the long-term safety of Keppra XR in patients with partial onset seizures.

Eligibility

Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Aguascalientes, Mexico

Monterey, Mexico

Gdansk, Poland

Poznan, Poland

Warszawa, Poland

Lodz, Poland

Katowice, Poland

Krakow, Poland

Bialystok, Poland

Northport, Alabama, United States

Dothan, Alabama, United States

Phoenix, Arizona, United States

Little Rock, Arkansas, United States

Loxahatchee, Florida, United States

Atlanta, Georgia, United States

Binghampton, New York, United States

Cedarhurst, New York, United States

Columbus, Ohio, United States

Toledo, Ohio, United States

Additional Information

Starting date: December 2007
Ending date: August 2009
Last updated: June 9, 2008

Page last updated: June 20, 2008

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