Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

NCT ID: NCT00143143

Last Updated: 2006-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2006-02-28

Brief Summary

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

Detailed Description

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Conditions

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Epilepsies, Partial Epilepsy, Complex Partial

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pregabalin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bonn, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Göttingen, , Germany

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Kehl, , Germany

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Innsbruck, , Austria

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Mauer bei Amstetten, , Austria

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Sankt Pölten, , Austria

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Vienna, , Austria

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Barrie, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Trois-Rivières, Quebec, Canada

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Marseille, Cedex 05, France

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Paris, Cedex 13, France

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Montpellier, Cedex 5, France

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Lille, Cedex, France

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Rennes, Cedex, France

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Colomiers, , France

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Dommartin-lès-Toul, , France

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Marseille, , France

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Strasbourg, , France

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Berlin, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Marburg, , Germany

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Ulm, , Germany

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Florence, , Italy

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Perugia, , Italy

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Pisa, , Italy

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Siena, , Italy

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Barcelona, Barcelona, Spain

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Girona, Gerona, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Donostia / San Sebastian, , Spain

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Glascow, Scotland, United Kingdom

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Fazakerley, Liverpool, , United Kingdom

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York, , United Kingdom

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, ,

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Countries

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Austria Canada France Germany Italy Lithuania Spain United Kingdom

Other Identifiers

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1008-000-164

Identifier Type: -

Identifier Source: org_study_id