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Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures

Information source: Pfizer
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: pregabalin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Summary

This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.

Clinical Details

Official title: An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Seizure frequency data for assessment of efficacy will be summarized.

Secondary outcome: The nature, frequency and intensity of adverse events and laboratory abnormalities will be described.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Completed the previous protocol and wish to continue to receive pregabalin.

- Diagnosis of epilepsy with partial seizures

Exclusion Criteria:

- Early withdrawal from the previous protocol, an episode of status epliepticus, or

primary generalized epilepsy.

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Beroun 266 01, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Brno 2 602 00, Czech Republic; Completed

Pfizer Investigational Site, Litomysl 570 14, Czech Republic; Completed

Pfizer Investigational Site, New Territories, Hong Kong; Terminated

Pfizer Investigational Site, Dnipropetrovsk 49005, Ukraine; Active, not recruiting

Pfizer Investigational Site, Dnipropetrovsk 49115, Ukraine; Active, not recruiting

Pfizer Investigational Site, Kharkiv 61018, Ukraine; Recruiting

Pfizer Investigational Site, Kharkiv 61068, Ukraine; Recruiting

Pfizer Investigational Site, Lugansk 91045, Ukraine; Active, not recruiting

Pfizer Investigational Site, Odessa 65025, Ukraine; Recruiting

Pfizer Investigational Site, Phoenix, Arizona 85003, United States; Completed

Pfizer Investigational Site, Sun City, Arizona 85351, United States; Not yet recruiting

Pfizer Investigational Site, Fayetteville, Arkansas 72703, United States; Terminated

Pfizer Investigational Site, Fullerton, California 92835, United States; Recruiting

Pfizer Investigational Site, Long Beach, California 90806, United States; Recruiting

Pfizer Investigational Site, Modesto, California 95355, United States; Recruiting

Pfizer Investigational Site, Murrieta, California 92562, United States; Recruiting

Pfizer Investigational Site, Newport Beach, California 92660, United States; Recruiting

Pfizer Investigational Site, Temecula, California 92591, United States; Recruiting

Pfizer Investigational Site, Denver, Colorado 80204, United States; Completed

Pfizer Investigational Site, Jacksonville, Florida 32209, United States; Active, not recruiting

Pfizer Investigational Site, Suwanee, Georgia 30024, United States; Terminated

Pfizer Investigational Site, Danville, Indiana 46122, United States; Terminated

Pfizer Investigational Site, Fort Wayne, Indiana 46805, United States; Completed

Pfizer Investigational Site, Kansas City, Kansas 66160, United States; Terminated

Pfizer Investigational Site, Bowling Green, Kentucky 42101, United States; Completed

Pfizer Investigational Site, Lexington, Kentucky 40536, United States; Completed

Pfizer Investigational Site, Houma, Louisiana 70363, United States; Active, not recruiting

Pfizer Investigational Site, Shreveport, Louisiana 71105-5634, United States; Completed

Pfizer Investigational Site, Pikesville, Maryland 21208, United States; Completed

Pfizer Investigational Site, Worcester, Massachusetts 01608, United States; Recruiting

Pfizer Investigational Site, Detroit, Michigan 48202, United States; Terminated

Pfizer Investigational Site, Flowood, Mississippi 39232, United States; Active, not recruiting

Pfizer Investigational Site, Great Falls, Montana 59405, United States; Recruiting

Pfizer Investigational Site, Cedarhurst, New York 11516, United States; Not yet recruiting

Pfizer Investigational Site, Charlotte, North Carolina 28209, United States; Recruiting

Pfizer Investigational Site, Charlotte, North Carolina 28203, United States; Recruiting

Pfizer Investigational Site, Columbus, Ohio 43210, United States; Completed

Pfizer Investigational Site, Oklahoma City, Oklahoma 73112, United States; Completed

Pfizer Investigational Site, Oklahoma City, Oklahoma 73120, United States; Completed

Pfizer Investigational Site, Nashville, Tennessee 37232, United States; Not yet recruiting

Pfizer Investigational Site, Dallas, Texas 75230, United States; Recruiting

Pfizer Investigational Site, Houston, Texas 77074, United States; Completed

Pfizer Investigational Site, San Antonio, Texas 78258, United States; Not yet recruiting

Pfizer Investigational Site, Temple, Texas 76508, United States; Recruiting

Pfizer Investigational Site, Salt Lake City, Utah 84107, United States; Completed

Pfizer Investigational Site, West Jordan, Utah 84088, United States; Completed

Pfizer Investigational Site, Milwaukee, Wisconsin 53226, United States; Completed

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: April 2008
Last updated: November 23, 2011

Page last updated: December 08, 2011

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