Pregabalin In Partial Seizures: An Open-Label, International, Multicenter Add-On Therapy Trial.

NCT ID: NCT00141427

Last Updated: 2021-01-25

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

PHASE4

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-05-31

Brief Summary

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To assess the clinical improvement (change in seizure frequency), safety and tolerability of patients with partial seizures following adjunctive therapy of pregabalin BID in addition to existing standard AEDs.

Detailed Description

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Conditions

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Seizures

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

* Male and female subjects with a diagnosis of partial epilepsy.
* 18 years and older.

Exclusion Criteria

* Having a treatable cause of seizure.
* Having a progressive neurological or systemic disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bruges, , Belgium

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Brussels, , Belgium

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Duffel, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Tielt, , Belgium

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Yvoir, , Belgium

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Helsinki, , Finland

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Kuopio, , Finland

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Tampere, , Finland

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Marseille, Cedex 05, France

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Montpellier, Cedex 5, France

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Lyon, Cedex, France

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Bayonne, , France

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Bordeaux, , France

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Grenoble, , France

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Lille, , France

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Marseille, , France

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Nancy, , France

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Nice, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Rennes, , France

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Strasbourg, , France

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Toulouse, , France

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Tours, , France

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The Hague, South Holland, Netherlands

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Alkmaar, , Netherlands

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Breda, , Netherlands

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Heeze, , Netherlands

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Hilversum, , Netherlands

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Oss, , Netherlands

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Southwest Heemstede, , Netherlands

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Katowice, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Braga, , Portugal

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Funchal, , Portugal

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Lisbon, , Portugal

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Matosinhos Municipality, , Portugal

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Ponta Delgada, , Portugal

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Porto, , Portugal

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Lausanne, , Switzerland

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Zurich, , Switzerland

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Zurich, , Switzerland

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Cambridge, Cambs, United Kingdom

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Truro, Cornwall, United Kingdom

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Plymouth, Devon, United Kingdom

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Glasgow, , United Kingdom

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Oxford, , United Kingdom

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Countries

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Belgium Finland France Netherlands Poland Portugal Switzerland United Kingdom

Related Links

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Other Identifiers

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A0081005

Identifier Type: -

Identifier Source: org_study_id

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