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

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00419393

Purpose

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.

Condition	Intervention	Phase
Epilepsy	Drug: Levetiracetam XR	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Levetiracetam

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	190
Study Start Date:	December 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Keppra XR: Experimental 1000 - 3000 mg/day Keppra XR (Levetiracetam XR)	Drug: Levetiracetam XR 500mg tablets 1000 - 3000mg/day flexible dosing duration of the trial

Eligibility

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419393

Hide Study Locations

Locations

United States, Alabama

Dothan, Alabama, United States

Northport, Alabama, United States
United States, Arizona

Phoenix, Arizona, United States

Phoenix, Arizona, United States
United States, Arkansas

Little Rock, Arkansas, United States
United States, California

Bakersfield, California, United States
United States, Florida

Loxahatchee, Florida, United States
United States, Georgia

Atlanta, Georgia, United States

Suwanee, Georgia, United States
United States, Kansas

Witchita, Kansas, United States
United States, Michigan

Detroit, Michigan, United States
United States, New Jersey

Camden, New Jersey, United States
United States, New York

Buffalo, New York, United States

Cedarhurst, New York, United States
United States, Ohio

Toledo, Ohio, United States
United States, Oklahoma

Tulsa, Oklahoma, United States
United States, Texas

San Antonio, Texas, United States
Mexico

Aguascalientes, Mexico

Guadalajara, Mexico

Guadalajara Jalisco, Mexico

Mexico City, Mexico

Mexico Df, Mexico

Monterrey, Mexico

Monterrey, Mexico
Poland

Bialystok, Poland

Poznan, Poland

Katowice, Poland

Lodz, Poland

Lublin, Poland

Gdansk, Poland

Szczecin, Poland

Warszawa, Poland
Russian Federation

Kalingrad, Russian Federation

Kazan, Russian Federation

Moscow, Russian Federation

Yaroslavl, Russian Federation

Samara, Russian Federation

St Petersburg, Russian Federation

St. Petersburg, Russian Federation

Moscow, Russian Federation

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center, MD

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01281
Study First Received:	January 4, 2007
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00419393 History of Changes
Health Authority:	United States: Food and Drug Administration; Poland: Ministry of Health; Mexico: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by UCB, Inc.:

Keppra XR
Levetiracetam XR
long term
partial seizures

Additional relevant MeSH terms:

Nootropic Agents
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Neuroprotective Agents
Protective Agents

Pharmacologic Actions
Epilepsy
Therapeutic Uses
Piracetam
Etiracetam
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 25, 2009