To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures

November 5, 2009 updated by: Pfizer

Pregabalin Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.

To evaluate the long-term safety and efficacy of pregabalin in patients with partial seizures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

455

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmont, Alberta, Canada, T5G 0B7
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T5H 3V9
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V52 1M9
        • Pfizer Investigational Site
      • Vancouver, British Columbia, Canada, V67 1Y6
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4Y 1J3
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35255
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35294-0021
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85712
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85712-2809
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
      • Pasadena, California, United States, 91105
        • Pfizer Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32610
        • Pfizer Investigational Site
      • Gainesville, Florida, United States, 32608-1197
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
      • Plantation, Florida, United States, 33317
        • Pfizer Investigational Site
      • Spring Hill, Florida, United States, 34609
        • Pfizer Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
      • Springfield, Illinois, United States, 62704
        • Pfizer Investigational Site
      • Springfield, Illinois, United States, 62702
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46254
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Pfizer Investigational Site
      • Kansas City, Kansas, United States, 66160-7314
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Pfizer Investigational Site
      • Baltimore, Maryland, United States, 21224
        • Pfizer Investigational Site
      • Greenbelt, Maryland, United States, 20770
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02130
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Pfizer Investigational Site
      • Ann Arbor, Michigan, United States, 48108
        • Pfizer Investigational Site
    • Minnesota
      • St. Paul, Minnesota, United States, 55102
        • Pfizer Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Pfizer Investigational Site
      • Columbia, Missouri, United States, 65212
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63110-1092
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
      • New York, New York, United States, 10016
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14642
        • Pfizer Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43210
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97227
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have met the inclusion criteria for the preceding double-blind study
  • Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

  • Cannot have absence seizures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety Efficacy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Estimate)

November 6, 2009

Last Update Submitted That Met QC Criteria

November 5, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1008-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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