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

Last updated: January 15, 2021
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Overall Status: Terminated

Phase

3

Condition

Epilepsy

Treatment

N/A

Clinical Study ID

NCT00524030
A0081047
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thescreening visit.
  • Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to thescreening visit.

Exclusion

Exclusion Criteria:

  • Current diagnosis of febrile seizures or seizures related to an ongoing acute medicalevent.
  • Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic orinfectious origin.
  • Primary generalized epilepsy or status epilepticus within the previous year.

Study Design

Total Participants: 161
Study Start date:
September 01, 2007
Estimated Completion Date:
June 30, 2011

Study 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.

Connect with a study center

  • Pfizer Investigational Site

    Beroun, 266 01
    Czechia

    Site Not Available

  • Pfizer Investigational Site

    Brno 2, 602 00
    Czechia

    Site Not Available

  • Pfizer Investigational Site

    Litomysl, 570 14
    Czechia

    Site Not Available

  • Pfizer Investigational Site

    New Territories,
    Hong Kong

    Site Not Available

  • Pfizer Investigational Site

    Dnipropetrovsk, 49115
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Kharkiv, 61018
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Lugansk, 91045
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Odessa, 65025
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Northport, Alabama 35476
    United States

    Site Not Available

  • Pfizer Investigational Site

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Pfizer Investigational Site

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Pfizer Investigational Site

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Pfizer Investigational Site

    Fullerton, California 92835
    United States

    Site Not Available

  • Pfizer Investigational Site

    Long Beach, California 90806
    United States

    Site Not Available

  • Pfizer Investigational Site

    Modesto, California 95355
    United States

    Site Not Available

  • Pfizer Investigational Site

    Murrieta, California 92562
    United States

    Site Not Available

  • Pfizer Investigational Site

    Newport Beach, California 92660
    United States

    Site Not Available

  • Pfizer Investigational Site

    Temecula, California 92591
    United States

    Site Not Available

  • Pfizer Investigational Site

    Denver, Colorado 80204
    United States

    Site Not Available

  • Pfizer Investigational Site

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Pfizer Investigational Site

    Melbourne, Florida 32901
    United States

    Site Not Available

  • Pfizer Investigational Site

    Miami, Florida 33126
    United States

    Site Not Available

  • Pfizer Investigational Site

    Sarasota, Florida 34233
    United States

    Site Not Available

  • Pfizer Investigational Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Pfizer Investigational Site

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Pfizer Investigational Site

    Lawrenceville, Georgia 30045
    United States

    Site Not Available

  • Pfizer Investigational Site

    Suwanee, Georgia 30024
    United States

    Site Not Available

  • Pfizer Investigational Site

    Anderson, Indiana 46016
    United States

    Site Not Available

  • Pfizer Investigational Site

    Danville, Indiana 46122
    United States

    Site Not Available

  • Pfizer Investigational Site

    Fort Wayne, Indiana 46805
    United States

    Site Not Available

  • Pfizer Investigational Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Pfizer Investigational Site

    Bowling Green, Kentucky 42101
    United States

    Site Not Available

  • Pfizer Investigational Site

    Lexington, Kentucky 40536-0284
    United States

    Site Not Available

  • Pfizer Investigational Site

    Houma, Louisiana 70363
    United States

    Site Not Available

  • Pfizer Investigational Site

    Shreveport, Louisiana 71105-5634
    United States

    Site Not Available

  • Pfizer Investigational Site

    Pikesville, Maryland 21208
    United States

    Site Not Available

  • Pfizer Investigational Site

    Worcester, Massachusetts 01608
    United States

    Site Not Available

  • Pfizer Investigational Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Pfizer Investigational Site

    Minneapolis, Minnesota 55422
    United States

    Site Not Available

  • Pfizer Investigational Site

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Pfizer Investigational Site

    Hattiesburg, Mississippi 39401-7246
    United States

    Site Not Available

  • Pfizer Investigational Site

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Pfizer Investigational Site

    Cedarhurst, New York 11516
    United States

    Site Not Available

  • Pfizer Investigational Site

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • Pfizer Investigational Site

    Rocky Mount, North Carolina 27804
    United States

    Site Not Available

  • Pfizer Investigational Site

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Pfizer Investigational Site

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Pfizer Investigational Site

    Altoona, Pennsylvania 16602
    United States

    Site Not Available

  • Pfizer Investigational Site

    Indiana, Pennsylvania 15701
    United States

    Site Not Available

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Pfizer Investigational Site

    Memphis, Tennessee 38163
    United States

    Site Not Available

  • Pfizer Investigational Site

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Pfizer Investigational Site

    Dallas, Texas 75230
    United States

    Site Not Available

  • Pfizer Investigational Site

    Houston, Texas 77074-2906
    United States

    Site Not Available

  • Pfizer Investigational Site

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Pfizer Investigational Site

    Temple, Texas 76508
    United States

    Site Not Available

  • Pfizer Investigational Site

    Murray, Utah 84107
    United States

    Site Not Available

  • Pfizer Investigational Site

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Pfizer Investigational Site

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Pfizer Investigational Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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