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

Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsies, Partial

Intervention: pregabalin 600 mg/day (Drug); pregabalin 150 mg/day (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 determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

Clinical Details

Official title: A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The percent of subjects who meet at least one of the 5 pre-specified exit criteria (which reflect a decrease in seizure control) during double-blind treatment.

Secondary outcome:

Pregabalin population PK and exposure-response analysis.

Percent of subjects exiting by group.

Percent of subjects completing double-blind treatment.

Percent of subjects seizure-free during: the last study month, the monotherapy phase, and the entire double-blind treatment phase.

Percent of subjects who met each of the exit events.

Mean time on pregabalin monotherapy.

Eligibility

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

Criteria:

Inclusion Criteria:

- Diagnosis of epilepsy with partial seizures.

- Males or females, age 18 years or older.

- Documented history of at least 4 partial seizures in the 8 weeks prior to the

screening visit.

- Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the

screening visit.

Exclusion Criteria:

- Current diagnosis of febrile seizures or seizures related to an ongoing acute medical

event.

- Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or

infectious origin.

- Primary generalized epilepsy or status epilepticus within the previous year.

Locations and Contacts

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

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

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

Pfizer Investigational Site, New Territories, Hong Kong; Recruiting

Pfizer Investigational Site, Dnipropetrovsk 49005, Ukraine; Recruiting

Pfizer Investigational Site, Dnipropetrovsk 49115, Ukraine; Recruiting

Pfizer Investigational Site, Kharkiv 61068, Ukraine; Recruiting

Pfizer Investigational Site, Lugansk 91045, Ukraine; Recruiting

Pfizer Investigational Site, Odessa 65025, Ukraine; Recruiting

Pfizer Investigational Site, Northport, Alabama 35476, United States; Recruiting

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

Pfizer Investigational Site, Phoenix, Arizona 85013, United States; Recruiting

Pfizer Investigational Site, Tucson, Arizona 85710, United States; Not yet recruiting

Pfizer Investigational Site, Tucson, Arizona 85712, United States; Not yet recruiting

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

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

Pfizer Investigational Site, Garden Grove, California 92845, United States; Recruiting

Pfizer Investigational Site, Los Angeles, California 90048, United States; Not yet recruiting

Pfizer Investigational Site, Modesto, California 95355, United States; Not yet 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, Aurora, Colorado 80013, United States; Recruiting

Pfizer Investigational Site, Centennial, Colorado 80112, United States; Recruiting

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

Pfizer Investigational Site, Lone Tree, Colorado 80124, United States; Recruiting

Pfizer Investigational Site, Jacksonville, Florida 32216, United States; Recruiting

Pfizer Investigational Site, Jacksonville, Florida 32209, United States; Recruiting

Pfizer Investigational Site, Melbourne, Florida 32901, United States; Active, not recruiting

Pfizer Investigational Site, Miami, Florida 33136, United States; Recruiting

Pfizer Investigational Site, Miami, Florida 33126, United States; Recruiting

Pfizer Investigational Site, Sarasota, Florida 34232, United States; Recruiting

Pfizer Investigational Site, Sarasota, Florida 34233, United States; Recruiting

Pfizer Investigational Site, Atlanta, Georgia 30309, United States; Terminated

Pfizer Investigational Site, Atlanta, Georgia 30342, United States; Terminated

Pfizer Investigational Site, Decatur, Georgia 30033, United States; Recruiting

Pfizer Investigational Site, Lawrenceville, Georgia 30045, United States; Recruiting

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

Pfizer Investigational Site, Flossmoor, Illinois 60422, United States; Not yet recruiting

Pfizer Investigational Site, Anderson, Indiana 46016, United States; Terminated

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

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

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

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

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

Pfizer Investigational Site, Houma, Louisiana 70363, United States; Recruiting

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

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

Pfizer Investigational Site, Framingham, Massachusetts 01701, United States; Recruiting

Pfizer Investigational Site, Worcester, Massachusetts 01605, United States; Recruiting

Pfizer Investigational Site, Worcester, Massachusetts 01604, United States; Recruiting

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

Pfizer Investigational Site, Minneapolis, Minnesota 55422, United States; Recruiting

Pfizer Investigational Site, Flowood, Mississippi 39232, United States; Recruiting

Pfizer Investigational Site, Hattiesburg, Mississippi 39401-7246, United States; Terminated

Pfizer Investigational Site, Nixa, Missouri 65714, United States; Recruiting

Pfizer Investigational Site, Springfield, Missouri 65807, United States; Recruiting

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

Pfizer Investigational Site, Cedarhurst, New York 11516, United States; Recruiting

Pfizer Investigational Site, Charlotte, North Carolina 28207, United States; Recruiting

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

Pfizer Investigational Site, Rocky Mount, North Carolina 27804, United States; Terminated

Pfizer Investigational Site, Cleveland, Ohio 44195, United States; Completed

Pfizer Investigational Site, Cleveland, Ohio 44106, United States; Recruiting

Pfizer Investigational Site, Columbus, Ohio 43210-1250, United States; Recruiting

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

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

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

Pfizer Investigational Site, Altoona, Pennsylvania 16602, United States; Terminated

Pfizer Investigational Site, Indiana, Pennsylvania 15701, United States; Recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19140, United States; Recruiting

Pfizer Investigational Site, Memphis, Tennessee 38104, United States; Recruiting

Pfizer Investigational Site, Memphis, Tennessee 38120, United States; Recruiting

Pfizer Investigational Site, Nashville, Tennessee 37232, United States; Recruiting

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

Pfizer Investigational Site, Houston, Texas 77074-2906, United States; Completed

Pfizer Investigational Site, San Antonio, Texas 78258, United States; Recruiting

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

Pfizer Investigational Site, Murray, Utah 84107, United States; Recruiting

Pfizer Investigational Site, Salt Lake City, Utah 84102, United States; Recruiting

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

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

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: September 2007
Last updated: September 22, 2010

Page last updated: October 04, 2010

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