Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

July 21, 2006 updated by: Pfizer

Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures

The primary purpose of the protocol is to evaluate the long-term safety of pregabalin in patients with partial seizures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

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
  • Austria
      • Innsbruck, Austria, A6020
        • Pfizer Investigational Site
      • Mauer Bei Amstetten, Austria, 3362
        • Pfizer Investigational Site
      • St Polten, Austria, A3100
        • Pfizer Investigational Site
      • Wien, Austria, 1090
        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T5G 0B7
        • Pfizer Investigational Site
    • British Columbia
      • 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, K1H 8L6
        • Pfizer Investigational Site
    • Quebec
      • Trois Rivieres, Quebec, Canada, G8Z 4K4
        • Pfizer Investigational Site
  • France
      • Colomiers, France, 31770
        • Pfizer Investigational Site
      • Dommartin Les Toul, France, 54201
        • Pfizer Investigational Site
      • Marseille Cedex 09, France, 13274
        • Pfizer Investigational Site
      • Strasbourg, France, 67091
        • Pfizer Investigational Site
    • Cedex
      • Lille, Cedex, France, 59037
        • Pfizer Investigational Site
      • Rennes, Cedex, France, 35033
        • Pfizer Investigational Site
    • Cedex 05
      • Marseille, Cedex 05, France, 13005
        • Pfizer Investigational Site
    • Cedex 13
      • Paris, Cedex 13, France, 75651
        • Pfizer Investigational Site
    • Cedex 5
      • Montpellier, Cedex 5, France, 34295
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • Pfizer Investigational Site
      • Berlin, Germany, 10365
        • Pfizer Investigational Site
      • Bielefeld, Germany, 33617
        • Pfizer Investigational Site
      • Bonn, Germany, 53127
        • Pfizer Investigational Site
      • Essen, Germany, 45147
        • Pfizer Investigational Site
      • Frankfurt, Germany, 60528
        • Pfizer Investigational Site
      • Freiburg, Germany, 79106
        • Pfizer Investigational Site
      • Goettingen, Germany, D-37075
        • Pfizer Investigational Site
      • Kehl, Germany, 77694
        • Pfizer Investigational Site
      • Marburg, Germany, 35039
        • Pfizer Investigational Site
      • ULM, Germany, 89075
        • Pfizer Investigational Site
  • Italy
      • Firenze, Italy, 50122
        • Pfizer Investigational Site
      • Perugia, Italy, 06123
        • Pfizer Investigational Site
      • Pisa, Italy, 56126
        • Pfizer Investigational Site
      • Siena, Italy, 53100
        • Pfizer Investigational Site
  • Lithuania
      • Vilnius, Lithuania, LT-2600
        • Pfizer Investigational Site
      • Vilnius, Lithuania, 2600
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Donostia-San Sebastian, Spain, 20014
        • Pfizer Investigational Site
      • Gerona, Spain, 17007
        • Pfizer Investigational Site
      • Madrid, Spain, 28034
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
  • United Kingdom
      • Fazakerley, Liverpool, United Kingdom, L9 7LJ
        • Pfizer Investigational Site
      • York, United Kingdom, Y031 8HE
        • Pfizer Investigational Site
    • Scotland
      • Glascow, Scotland, United Kingdom, G11 6NT
        • 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:

  • Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin
  • Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening
  • Be currently taking 1 to 3 AEDs.

Exclusion Criteria:

  • Have a treatable cause of seizures
  • Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication

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 assessments are performed at quarterly visits up until the study is closed.

Secondary Outcome Measures

Outcome Measure
Seizure frequency is assessed throughout the study until the study is closed.

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

September 1, 2001

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

July 24, 2006

Last Update Submitted That Met QC Criteria

July 21, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1008-000-164

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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