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

March 4, 2015 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 determine long-term safety and efficacy of pregabalin in patients with partial seizures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

337

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

        • Pfizer Investigational Site
  • Australia
    • Australian Capital Territory
      • Deakin, Australian Capital Territory, Australia, 2600
        • Pfizer Investigational Site
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Pfizer Investigational Site
      • Chastwood, New South Wales, Australia, 2067
        • Pfizer Investigational Site
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • Pfizer Investigational Site
      • Maroochydore, Queensland, Australia, 4558
        • Pfizer Investigational Site
    • Victoria
      • Footscray, Victoria, Australia, 3011
        • Pfizer Investigational Site
      • Parkville, Victoria, Australia, 3050
        • Pfizer Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Pfizer Investigational Site
  • Austria
      • Auenbruggerplatz 22, Austria, A-8035 GRAZ
        • Pfizer Investigational Site
      • Graz, Austria, 8020
        • Pfizer Investigational Site
      • Innsbruck, Austria, A6020
        • Pfizer Investigational Site
      • Linz, Austria, 4020
        • Pfizer Investigational Site
      • Wien, Austria, 1220
        • Pfizer Investigational Site
  • Belgium
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1J 1Z4
        • Pfizer Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T5G 0B7
        • Pfizer Investigational Site
    • British Columbia
      • Penticton, British Columbia, Canada, V2A 4V8
        • Pfizer Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Pfizer Investigational Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 4S5
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6A 5A5
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1L 8L6
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5T 2S8
        • Pfizer Investigational Site
      • Windsor, Ontario, Canada, N8X5A6
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3A 2B4
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Pfizer Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 1A5
        • Pfizer Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, BE10362
        • Pfizer Investigational Site
      • Bernau, Germany, 16321
        • Pfizer Investigational Site
      • Bonn, Germany, 53127
        • Pfizer Investigational Site
      • Dresden, Germany, 01307
        • Pfizer Investigational Site
      • Erlangen, Germany, 91054
        • Pfizer Investigational Site
      • Essen, Germany, 45147
        • Pfizer Investigational Site
      • Frankfurt, Germany, HE 60528
        • Pfizer Investigational Site
      • Freiburg, Germany, 79106
        • Pfizer Investigational Site
      • Goettingen, Germany, D-37075
        • Pfizer Investigational Site
      • Hamburg, Germany, D-22337
        • Pfizer Investigational Site
      • Mainz, Germany, 55101
        • Pfizer Investigational Site
      • Muenchen, Germany, 81377
        • Pfizer Investigational Site
    • BW
      • Ulm, BW, Germany, 89081
        • Pfizer Investigational Site
  • Netherlands
      • AE Breda, Netherlands, 4836
        • Pfizer Investigational Site
      • Blaricum, Netherlands, 1261 AN
        • Pfizer Investigational Site
      • Ve Heeze, Netherlands, 5591
        • Pfizer Investigational Site
  • Poland
      • Bialystok, Poland, 15-276
        • Pfizer Investigational Site
      • Bydgoszcz, Poland, 85-826
        • Pfizer Investigational Site
      • Choroszcz, Poland, 16-070
        • Pfizer Investigational Site
      • Gdansk, Poland, 80-211
        • Pfizer Investigational Site
      • Gdansk, Poland, 82-803
        • Pfizer Investigational Site
      • Grudziadz, Poland, 86-300
        • Pfizer Investigational Site
      • Katowice, Poland, 46-645
        • Pfizer Investigational Site
      • Krakow, Poland, 31-112
        • Pfizer Investigational Site
      • Lublin, Poland, 20-718
        • Pfizer Investigational Site
      • Mosina, Poland, 62-050
        • Pfizer Investigational Site
      • Olsztyn, Poland, 10-561
        • Pfizer Investigational Site
      • Plock, Poland, 09-402
        • Pfizer Investigational Site
      • Poznan, Poland, 60-780
        • Pfizer Investigational Site
      • Poznan, Poland, 61-285
        • Pfizer Investigational Site
      • Torun, Poland, 87-100
        • Pfizer Investigational Site
      • Warsaw, Poland, 00-909
        • Pfizer Investigational Site
      • Warsaw, Poland, 02-957
        • Pfizer Investigational Site
      • Warszawa, Poland, 00-909
        • Pfizer Investigational Site
      • Warszawa, Poland
        • Pfizer Investigational Site
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Pfizer Investigational Site
      • Porto, Portugal, 4099
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Girona, Spain, 17007
        • Pfizer Investigational Site
      • Granada, Spain, 18013
        • Pfizer Investigational Site
      • Madrid, Spain, 28034
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
      • Malaga, Spain, 29010
        • Pfizer Investigational Site
      • Zaragoza, Spain, 50009
        • Pfizer Investigational Site
  • United Kingdom
      • Blackpool, United Kingdom, FY3 8BP
        • Pfizer Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G11 6NT
        • Pfizer Investigational Site
      • Leeds, United Kingdom, LS9 7TF
        • Pfizer Investigational Site
      • London, United Kingdom, E1 1BB
        • Pfizer Investigational Site
      • Northampton, United Kingdom, NN1 5BD
        • Pfizer Investigational Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Pfizer Investigational Site
    • N. York
      • Middlesborough, N. York, United Kingdom, TS5 5AZ
        • Pfizer Investigational Site
    • Tyne & Wear
      • Washington, Tyne & Wear, United Kingdom, NE38 9JZ
        • 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 be pregnant or considering becoming pregnant during the course of the study.
  • Cannot be receiving any concomitant medication that could alter the effectiveness of the pregabalin response or affect seizure frequency.

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

March 1, 2002

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1008-114

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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