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To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

Primary Purpose

Seizure Disorder, Partial

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seizure Disorder, Partial

Eligibility Criteria

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

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 have absence seizures

Sites / Locations

  • 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
  • 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
  • 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
  • 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

Safety Efficacy

Secondary Outcome Measures

Full Information

First Posted
August 30, 2005
Last Updated
December 28, 2006
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00141245
Brief Title
To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.
Official Title
Pregabalin Open-Label, Multicenter Add-On Trial Following a 4-Day Double-Blind Transition Period to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
To evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
325 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pregabalin
Primary Outcome Measure Information:
Title
Safety Efficacy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 have absence seizures
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
Deakin
State/Province
Australian Capital Territory
ZIP/Postal Code
2600
Country
Australia
Facility Name
Pfizer Investigational Site
City
Chatswood
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
Facility Name
Pfizer Investigational Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Pfizer Investigational Site
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Pfizer Investigational Site
City
Heidelberg
ZIP/Postal Code
VIC 3084
Country
Australia
Facility Name
Pfizer Investigational Site
City
Woodville
ZIP/Postal Code
5011
Country
Australia
Facility Name
Pfizer Investigational Site
City
Graz
ZIP/Postal Code
A-8035
Country
Austria
Facility Name
Pfizer Investigational Site
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Pfizer Investigational Site
City
Duffel
ZIP/Postal Code
2570
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Pfizer Investigational Site
City
Turku
ZIP/Postal Code
FIN-20521
Country
Finland
Facility Name
Pfizer Investigational Site
City
Lyon
State/Province
Cedex
ZIP/Postal Code
69694
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
State/Province
Cedex
ZIP/Postal Code
75674
Country
France
Facility Name
Pfizer Investigational Site
City
Tours
State/Province
Cedex
ZIP/Postal Code
37044
Country
France
Facility Name
Pfizer Investigational Site
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Pfizer Investigational Site
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Pfizer Investigational Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Pfizer Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Pfizer Investigational Site
City
Goettingen
ZIP/Postal Code
D-37075
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
22292
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Pfizer Investigational Site
City
Moenchengladbach
ZIP/Postal Code
41179
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Pfizer Investigational Site
City
Munich
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Pfizer Investigational Site
City
Firenze
ZIP/Postal Code
50135
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Perugia
ZIP/Postal Code
06123
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Heemstede
ZIP/Postal Code
2103 SW
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Heeze
ZIP/Postal Code
5591 VE
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Parow
State/Province
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Durban
ZIP/Postal Code
4052
Country
South Africa
Facility Name
Pfizer Investigational Site
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Gerona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
S-413 45
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lavigny, LE
ZIP/Postal Code
CN-1775
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Tschugg
ZIP/Postal Code
CH-3233
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Bimingham
ZIP/Postal Code
B15 2QZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bucks
ZIP/Postal Code
SL9 ORJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9ND
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Liverpool
ZIP/Postal Code
L9 1AE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
York
ZIP/Postal Code
Y03 7HE
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

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