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

December 28, 2006 updated by: Pfizer

Pregabalin BID 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 tolerability of pregabalin in patients with partial seizures.

Study Overview

Status

Completed

Conditions

Seizure Disorder, Partial

Intervention / Treatment

Drug: Pregabalin

Study Type

Interventional

Enrollment

750

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
  - Calgary, Alberta, Canada, T2N 2T9
    - Pfizer Investigational Site
  - Edmonton, Alberta, Canada, T5G 0B7
    - Pfizer Investigational Site
  - Edmonton, Alberta, Canada, T5H 3V9
    - Pfizer Investigational Site
- Ontario
  - Barrie, Ontario, Canada, L4M 4S5
    - Pfizer Investigational Site
  - London, Ontario, Canada, N6A 5A5
    - Pfizer Investigational Site
  - Toronto, Ontario, Canada, M5C 1R6
    - Pfizer Investigational Site
United States
- Arizona
  - Phoenix, Arizona, United States, 85013
    - Pfizer Investigational Site
  - Tucson, Arizona, United States, 85724
    - Pfizer Investigational Site
- California
  - Bakersfield, California, United States, 93301
    - Pfizer Investigational Site
  - Berkeley, California, United States, 94705
    - Pfizer Investigational Site
  - Concord, California, United States, 94520
    - Pfizer Investigational Site
  - Covina, California, United States, 91723
    - Pfizer Investigational Site
  - El Cajon, California, United States, 92021
    - Pfizer Investigational Site
  - Encino, California, United States, 91436
    - Pfizer Investigational Site
  - La Mesa, California, United States, 91942
    - Pfizer Investigational Site
  - Marina del Ray, California, United States, 90292
    - Pfizer Investigational Site
  - Martinez, California, United States, 94553
    - Pfizer Investigational Site
  - Northridge, California, United States, 91325
    - Pfizer Investigational Site
  - Pinole, California, United States, 94564
    - Pfizer Investigational Site
  - Redondo Beach, California, United States, 90277
    - Pfizer Investigational Site
  - Sacramento, California, United States, 95823
    - Pfizer Investigational Site
  - Sacramento, California, United States, 95816
    - Pfizer Investigational Site
  - San Diego, California, United States, 92120
    - Pfizer Investigational Site
  - Santa Monica, California, United States, 90404
    - Pfizer Investigational Site
  - Walnut Creek, California, United States, 94598
    - Pfizer Investigational Site
- Colorado
  - Denver, Colorado, United States, 80218
    - Pfizer Investigational Site
  - Englewood, Colorado, United States, 80110
    - Pfizer Investigational Site
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Pfizer Investigational Site
- Florida
  - Miami, Florida, United States, 33173
    - Pfizer Investigational Site
  - Miami, Florida, United States, 33176
    - Pfizer Investigational Site
  - Orlando, Florida, United States, 32806
    - Pfizer Investigational Site
  - Tampa, Florida, United States, 33609
    - Pfizer Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Pfizer Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - Pfizer Investigational Site
  - Chicago, Illinois, United States, 60612
    - Pfizer Investigational Site
  - Chicago, Illinois, United States, 60640
    - Pfizer Investigational Site
- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
    - Pfizer Investigational Site
  - Louisville, Kentucky, United States, 40202
    - Pfizer Investigational Site
- Louisiana
  - Ruston, Louisiana, United States, 71270
    - Pfizer Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21287
    - Pfizer Investigational Site
- Michigan
  - Detroit, Michigan, United States, 48202-2689
    - Pfizer Investigational Site
- Minnesota
  - Golden Valley, Minnesota, United States, 55422
    - Pfizer Investigational Site
  - Minneapolis, Minnesota, United States, 55422
    - Pfizer Investigational Site
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - Pfizer Investigational Site
- Missouri
  - St. Louis, Missouri, United States, 63110
    - Pfizer Investigational Site
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - Pfizer Investigational Site
  - Las Vegas, Nevada, United States, 89106
    - Pfizer Investigational Site
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - Pfizer Investigational Site
  - Dover, New Hampshire, United States, 03820
    - Pfizer Investigational Site
- New Jersey
  - New Brunswick, New Jersey, United States, 08903
    - Pfizer Investigational Site
  - New Brunswick, New Jersey, United States, 08901
    - Pfizer Investigational Site
  - Ridgewood, New Jersey, United States, 07450
    - Pfizer Investigational Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - Pfizer Investigational Site
  - Albuquerque, New Mexico, United States, 87131-5021
    - Pfizer Investigational Site
  - Albuquerque, New Mexico, United States, 87131-5281
    - Pfizer Investigational Site
- New York
  - Bronx, New York, United States, 10467
    - Pfizer Investigational Site
  - Brooklyn, New York, United States, 11203
    - Pfizer Investigational Site
  - New York, New York, United States, 10021
    - Pfizer Investigational Site
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - Pfizer Investigational Site
  - Asheville, North Carolina, United States, 28806
    - Pfizer Investigational Site
  - Raleigh, North Carolina, United States, 27607
    - Pfizer Investigational Site
  - Winston-Salem, North Carolina, United States, 27103
    - Pfizer Investigational Site
  - Winston-Salem, North Carolina, United States, 37103
    - Pfizer Investigational Site
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - Pfizer Investigational Site
  - Cincinnati, Ohio, United States, 45219
    - Pfizer Investigational Site
  - Columbus, Ohio, United States, 43210
    - Pfizer Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104-5068
    - Pfizer Investigational Site
- Oregon
  - Medford, Oregon, United States, 97504
    - Pfizer Investigational Site
  - Portland, Oregon, United States, 97210
    - Pfizer Investigational Site
  - Portland, Oregon, United States, 97201
    - Pfizer Investigational Site
  - Portland, Oregon, United States, 97209
    - Pfizer Investigational Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Pfizer Investigational Site
  - Philadelphia, Pennsylvania, United States, 19107
    - Pfizer Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15212
    - Pfizer Investigational Site
  - Ridley Park, Pennsylvania, United States, 19078
    - Pfizer Investigational Site
  - Upland, Pennsylvania, United States, 19013
    - Pfizer Investigational Site
- Rhode Island
  - Cranston, Rhode Island, United States, 02920
    - Pfizer Investigational Site
- Tennessee
  - Knoxville, Tennessee, United States, 37916
    - Pfizer Investigational Site
  - Memphis, Tennessee, United States, 38103
    - Pfizer Investigational Site
- Texas
  - Dallas, Texas, United States, 75216
    - Pfizer Investigational Site
  - Dallas, Texas, United States, 75230
    - Pfizer Investigational Site
  - Dallas, Texas, United States, 75243
    - Pfizer Investigational Site
  - Fort Worth, Texas, United States, 76107
    - Pfizer Investigational Site
  - Fort Worth, Texas, United States, 76107-2699
    - Pfizer Investigational Site
  - Houston, Texas, United States, 77030
    - Pfizer Investigational Site
  - Houston, Texas, United States, 77025
    - Pfizer Investigational Site
  - Houston, Texas, United States, 77002
    - Pfizer Investigational Site
  - Lubbock, Texas, United States, 79410
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78229
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78207
    - Pfizer Investigational Site
- Virginia
  - Alexandria, Virginia, United States, 22304
    - Pfizer Investigational Site
  - Alexandria, Virginia, United States, 22311
    - Pfizer Investigational Site
  - Charlottesville, Virginia, United States, 22908
    - Pfizer Investigational Site
  - Roanoke, Virginia, United States, 24014
    - Pfizer Investigational Site
  - Roanoke, Virginia, United States, 24016
    - Pfizer Investigational Site
  - Sterling, Virginia, United States, 20165
    - Pfizer Investigational Site
- Washington
  - Bellevue, Washington, United States, 98004
    - Pfizer Investigational Site
  - Bellvue, Washington, United States, 98004
    - Pfizer Investigational Site
  - Spokane, Washington, United States, 99202
    - Pfizer Investigational Site
  - Spokane, Washington, United States, 99204
    - Pfizer Investigational Site
- West Virginia
  - Morgantown, West Virginia, United States, 26507
    - Pfizer Investigational Site
- Wisconsin
  - Marshfield, Wisconsin, United States, 54449
    - Pfizer Investigational Site
  - Milwaukee, Wisconsin, United States, 53226
    - 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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Must have met the inclusion criteria for 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 Tolerability

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

November 1, 1999

Study Completion

July 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)

January 1, 2007

Last Update Submitted That Met QC Criteria

December 28, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

1008-035

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.