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

Primary Purpose

Seizures

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizures

Eligibility Criteria

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

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Reduction in seizure frequency.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2005
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00141427
Brief Title
Pregabalin In Partial Seizures: An Open-Label, International, Multicenter Add-On Therapy Trial.
Official Title
Pregabalin In Partial Seizures (Preps) : An Open-Label, International, Multicenter Add-On Therapy Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
540 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pregabalin
Primary Outcome Measure Information:
Title
Reduction in seizure frequency.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
8000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Duffel
ZIP/Postal Code
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
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Liege
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Tielt
ZIP/Postal Code
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
Marseille
State/Province
Cedex 05
ZIP/Postal Code
13005
Country
France
Facility Name
Pfizer Investigational Site
City
Montpellier
State/Province
Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon
State/Province
Cedex
ZIP/Postal Code
69694
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
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Pfizer Investigational Site
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Pfizer Investigational Site
City
Nice Cedex
ZIP/Postal Code
06031
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Pfizer Investigational Site
City
Rennes
ZIP/Postal Code
35033
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
31403
Country
France
Facility Name
Pfizer Investigational Site
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Pfizer Investigational Site
City
Den Haag
State/Province
ZH
ZIP/Postal Code
2512 VA
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Alkmaar
ZIP/Postal Code
NL-1815 JD
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Breda
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Heeze
ZIP/Postal Code
5591 VE
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Hilversum
ZIP/Postal Code
NL-1213 XZ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Oss
ZIP/Postal Code
5342 BT
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Southwest Heemstede
ZIP/Postal Code
2103
Country
Netherlands
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
Funchal
ZIP/Postal Code
9000-168
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1169-050
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
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
8008
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Cambridge
State/Province
Cambs
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Oxford
ZIP/Postal Code
OX2 6HE
Country
United Kingdom
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081005&StudyName=Pregabalin+In+Partial+Seizures%3A+An+Open%2DLabel%2C+International%2C+Multicenter+Add%2DOn+Therapy+Trial%2E
Description
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Learn more about this trial

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

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