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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
337

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Safety Efficacy

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2002

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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