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Pregabalin In Partial Seizures Extension Study (PREPS EXT)

Primary Purpose

Seizures

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pregabalin

About this trial

This is an interventional treatment trial for Seizures focused on measuring phase 4, open label, seizures, epilepsy, add-on therapy, pregabalin, lyrica

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: met the inclusion/exclusion criteria for A0081005 have completed the 21-week study and have shown a significant clinical response and wish to continue treatment Exclusion Criteria: Having a treatable cause of seizure. Having a progressive neurological or systemic disorder

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Outcomes

Primary Outcome Measures

Reduction in seizure frequency.

Secondary Outcome Measures

Seizure-free patients during each 3-month period

Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures).

Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures).

Full Information

NCT ID

NCT00143130

First Posted

August 31, 2005

Last Updated

January 26, 2021

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00143130

Brief Title

Pregabalin In Partial Seizures Extension Study

Acronym

PREPS EXT

Official Title

Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seizures

Keywords

phase 4, open label, seizures, epilepsy, add-on therapy, pregabalin, lyrica

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

227 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Intervention Description

Pregabalin

Primary Outcome Measure Information:

Title

Reduction in seizure frequency.

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Seizure-free patients during each 3-month period

Time Frame

18 Months

Title

Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures).

Time Frame

18 Months

Title

Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures).

Time Frame

18 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Brugge

ZIP/Postal Code

B-8000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Duffel

ZIP/Postal Code

B-2570

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Leuven

ZIP/Postal Code

B-3000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Tielt

ZIP/Postal Code

B-8700

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Helsinki

ZIP/Postal Code

00250

Country

Finland

Facility Name

Pfizer Investigational Site

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

Pfizer Investigational Site

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

Pfizer Investigational Site

City

Paris

State/Province

Cedex 14

ZIP/Postal Code

75674

Country

France

Facility Name

Pfizer Investigational Site

City

Lille

State/Province

Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Pfizer Investigational Site

City

Lyon

State/Province

Cedex

ZIP/Postal Code

69694

Country

France

Facility Name

Pfizer Investigational Site

City

Marsille

State/Province

Cedex

ZIP/Postal Code

13385

Country

France

Facility Name

Pfizer Investigational Site

City

Rennes

State/Province

Cedex

ZIP/Postal Code

35033

Country

France

Facility Name

Pfizer Investigational Site

City

Bayonne

ZIP/Postal Code

64109

Country

France

Facility Name

Pfizer Investigational Site

City

Bordeaux Cedex

ZIP/Postal Code

33076

Country

France

Facility Name

Pfizer Investigational Site

City

Grenoble Cedex

ZIP/Postal Code

38043

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille 13

ZIP/Postal Code

13009

Country

France

Facility Name

Pfizer Investigational Site

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Pfizer Investigational Site

City

Nancy

ZIP/Postal Code

54000

Country

France

Facility Name

Pfizer Investigational Site

City

Nice

ZIP/Postal Code

Cedex 06002

Country

France

Facility Name

Pfizer Investigational Site

City

Paris Cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

Pfizer Investigational Site

City

Paris Cedex 14

ZIP/Postal Code

75674

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75019

Country

France

Facility Name

Pfizer Investigational Site

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Pfizer Investigational Site

City

Toulouse

ZIP/Postal Code

31043

Country

France

Facility Name

Pfizer Investigational Site

City

Tours Cedex

ZIP/Postal Code

37044

Country

France

Facility Name

Pfizer Investigational Site

City

Katowice

ZIP/Postal Code

40-635

Country

Poland

Facility Name

Pfizer Investigational Site

City

Krakow

ZIP/Postal Code

31-523

Country

Poland

Facility Name

Pfizer Investigational Site

City

Lublin

ZIP/Postal Code

27-718

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

00-416

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

02-957

Country

Poland

Facility Name

Pfizer Investigational Site

City

Wroclaw

ZIP/Postal Code

50-420

Country

Poland

Facility Name

Pfizer Investigational Site

City

Braga

ZIP/Postal Code

4701-965

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Funchal

ZIP/Postal Code

9000-168

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Lisboa

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Matosinhos

ZIP/Postal Code

4454-509

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Ponta Delgada

ZIP/Postal Code

9500-370

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Ponta Delgada

ZIP/Postal Code

9500

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Pfizer Investigational Site

City

Lausanne

ZIP/Postal Code

CH-1011

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Zurich

ZIP/Postal Code

CH-8008

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Zurich

ZIP/Postal Code

CH-8091

Country

Switzerland

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081015&StudyName=Pregabalin%20In%20Partial%20Seizures%20Extension%20Study

Description

To obtain contact information for a study center near you, click here.

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Pregabalin In Partial Seizures Extension Study (PREPS EXT)

Seizures

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial