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

December 28, 2006 updated by: Pfizer

Pregabalin Open-Label, Multicenter Add-On Trial Following a 4-Day Double-Blind Transition Period to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

325

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

  • Australia
      • Heidelberg, Australia, VIC 3084
        • Pfizer Investigational Site
      • Woodville, Australia, 5011
        • Pfizer Investigational Site
    • Australian Capital Territory
      • Deakin, Australian Capital Territory, Australia, 2600
        • Pfizer Investigational Site
    • New South Wales
      • Chatswood, New South Wales, Australia, 2067
        • Pfizer Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • Pfizer Investigational Site
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Pfizer Investigational Site
  • Austria
      • Graz, Austria, A-8035
        • Pfizer Investigational Site
      • Innsbruck, Austria, A-6020
        • Pfizer Investigational Site
  • Belgium
      • Duffel, Belgium, 2570
        • Pfizer Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • Pfizer Investigational Site
      • Turku, Finland, FIN-20521
        • Pfizer Investigational Site
  • France
      • Dijon, France, 21000
        • Pfizer Investigational Site
      • Paris Cedex 13, France, 75651
        • Pfizer Investigational Site
      • Roubaix, France, 59100
        • Pfizer Investigational Site
    • Cedex
      • Lyon, Cedex, France, 69694
        • Pfizer Investigational Site
      • Paris, Cedex, France, 75674
        • Pfizer Investigational Site
      • Tours, Cedex, France, 37044
        • Pfizer Investigational Site
  • Germany
      • Erlangen, Germany, 91054
        • Pfizer Investigational Site
      • Freiburg, Germany, 79106
        • Pfizer Investigational Site
      • Goettingen, Germany, D-37075
        • Pfizer Investigational Site
      • Hamburg, Germany, 22292
        • Pfizer Investigational Site
      • Mainz, Germany, 55131
        • Pfizer Investigational Site
      • Moenchengladbach, Germany, 41179
        • Pfizer Investigational Site
      • Muenster, Germany, 48149
        • Pfizer Investigational Site
      • Munich, Germany, D-81377
        • Pfizer Investigational Site
  • Italy
      • Firenze, Italy, 50135
        • Pfizer Investigational Site
      • Pavia, Italy, 27100
        • Pfizer Investigational Site
      • Perugia, Italy, 06123
        • Pfizer Investigational Site
      • Pisa, Italy, 56126
        • Pfizer Investigational Site
  • Netherlands
      • Heemstede, Netherlands, 2103 SW
        • Pfizer Investigational Site
      • Heeze, Netherlands, 5591 VE
        • Pfizer Investigational Site
  • South Africa
      • Durban, South Africa, 4052
        • Pfizer Investigational Site
    • Cape Town
      • Parow, Cape Town, South Africa, 7505
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Gerona, Spain, 17007
        • Pfizer Investigational Site
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20014
        • Pfizer Investigational Site
  • Sweden
      • Goteborg, Sweden, S-413 45
        • Pfizer Investigational Site
  • Switzerland
      • Lavigny, LE, Switzerland, CN-1775
        • Pfizer Investigational Site
      • Tschugg, Switzerland, CH-3233
        • Pfizer Investigational Site
  • United Kingdom
      • Bimingham, United Kingdom, B15 2QZ
        • Pfizer Investigational Site
      • Bucks, United Kingdom, SL9 ORJ
        • Pfizer Investigational Site
      • Dundee, United Kingdom, DD1 9ND
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G11 6NT
        • Pfizer Investigational Site
      • Liverpool, United Kingdom, L9 1AE
        • Pfizer Investigational Site
      • York, United Kingdom, Y03 7HE
        • 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 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
  • Masking: NONE

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

October 1, 1998

Study Completion

November 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

  • 1008-012

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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