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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
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: Terminated

Sponsored by: Pfizer

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

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: Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria

Secondary outcome:

Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria

Percentage of Participants Completing 20 Weeks of Double-Blind Treatment

Percentage of Participants Who Met Protocol-Specified Exit Events

Mean Time on Pregabalin Monotherapy

Percentage of Seizure-Free Participants by Study Phase

Pregabalin Population Pharmacokinetics (PK)

Pregabalin Exposure-Response Analysis

Detailed description: After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on September 7, 2011.

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 Investigational Site, Beroun 266 01, Czech Republic

Pfizer Investigational Site, Brno 2 602 00, Czech Republic

Pfizer Investigational Site, Litomysl 570 14, Czech Republic

Pfizer Investigational Site, New Territories, Hong Kong

Pfizer Investigational Site, Dnipropetrovsk 49027, Ukraine

Pfizer Investigational Site, Dnipropetrovsk 49115, Ukraine

Pfizer Investigational Site, Kharkiv 61018, Ukraine

Pfizer Investigational Site, Kharkiv 61068, Ukraine

Pfizer Investigational Site, Lugansk 91045, Ukraine

Pfizer Investigational Site, Odessa 65025, Ukraine

Pfizer Investigational Site, Northport, Alabama 35476, United States

Pfizer Investigational Site, Phoenix, Arizona 85003, United States

Pfizer Investigational Site, Phoenix, Arizona 85013, United States

Pfizer Investigational Site, Sun City, Arizona 85351, United States

Pfizer Investigational Site, Fayetteville, Arkansas 72703, United States

Pfizer Investigational Site, Fullerton, California 92835, United States

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

Pfizer Investigational Site, Modesto, California 95355, United States

Pfizer Investigational Site, Murrieta, California 92562, United States

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

Pfizer Investigational Site, Temecula, California 92591, United States

Pfizer Investigational Site, Denver, Colorado 80204, United States

Pfizer Investigational Site, Jacksonville, Florida 32209, United States

Pfizer Investigational Site, Melbourne, Florida 32901, United States

Pfizer Investigational Site, Miami, Florida 33126, United States

Pfizer Investigational Site, Miami, Florida 33136, United States

Pfizer Investigational Site, Sarasota, Florida 34232, United States

Pfizer Investigational Site, Sarasota, Florida 34233, United States

Pfizer Investigational Site, Atlanta, Georgia 30309, United States

Pfizer Investigational Site, Atlanta, Georgia 30342, United States

Pfizer Investigational Site, Decatur, Georgia 30033, United States

Pfizer Investigational Site, Lawrenceville, Georgia 30045, United States

Pfizer Investigational Site, Suwanee, Georgia 30024, United States

Pfizer Investigational Site, Anderson, Indiana 46016, United States

Pfizer Investigational Site, Danville, Indiana 46122, United States

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

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

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

Pfizer Investigational Site, Lexington, Kentucky 40536-0284, United States

Pfizer Investigational Site, Lexington, Kentucky 40536, United States

Pfizer Investigational Site, Houma, Louisiana 70363, United States

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

Pfizer Investigational Site, Pikesville, Maryland 21208, United States

Pfizer Investigational Site, Worcester, Massachusetts 01605, United States

Pfizer Investigational Site, Worcester, Massachusetts 01608, United States

Pfizer Investigational Site, Detroit, Michigan 48202, United States

Pfizer Investigational Site, Minneapolis, Minnesota 55422, United States

Pfizer Investigational Site, Flowood, Mississippi 39232, United States

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

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

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

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

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

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

Pfizer Investigational Site, Cleveland, Ohio 44195, United States

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

Pfizer Investigational Site, Columbus, Ohio 43210, United States

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

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

Pfizer Investigational Site, Altoona, Pennsylvania 16602, United States

Pfizer Investigational Site, Indiana, Pennsylvania 15701, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19140, United States

Pfizer Investigational Site, Memphis, Tennessee 38120, United States

Pfizer Investigational Site, Memphis, Tennessee 38163, United States

Pfizer Investigational Site, Nashville, Tennessee 37232, United States

Pfizer Investigational Site, Dallas, Texas 75230, United States

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

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

Pfizer Investigational Site, Temple, Texas 76508, United States

Pfizer Investigational Site, Murray, Utah 84107, United States

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

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

Pfizer Investigational Site, Milwaukee, Wisconsin 53226, United States

Additional Information

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

Starting date: September 2007
Last updated: May 15, 2012

Page last updated: August 23, 2015

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