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Evaluation of 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 be pregnant or considering becoming pregnant during the course of the study. Cannot be receiving any concomitant medication that could alter the effectiveness of the pregabalin response or affect seizure frequency.

Sites / Locations

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

Primary Outcome Measures

Safety Efficacy

Secondary Outcome Measures

Full Information

First Posted
September 6, 2005
Last Updated
March 4, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00150293
Brief Title
Evaluation of Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.
Official Title
Pregabalin Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2002 (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 determine 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
337 (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 be pregnant or considering becoming pregnant during the course of the study. Cannot be receiving any concomitant medication that could alter the effectiveness of the pregabalin response or affect seizure frequency.
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
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Pfizer Investigational Site
City
Chastwood
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
Facility Name
Pfizer Investigational Site
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Pfizer Investigational Site
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Pfizer Investigational Site
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Pfizer Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Pfizer Investigational Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Pfizer Investigational Site
City
Auenbruggerplatz 22
ZIP/Postal Code
A-8035 GRAZ
Country
Austria
Facility Name
Pfizer Investigational Site
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Pfizer Investigational Site
City
Innsbruck
ZIP/Postal Code
A6020
Country
Austria
Facility Name
Pfizer Investigational Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Pfizer Investigational Site
City
Wien
ZIP/Postal Code
1220
Country
Austria
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 4V8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 4S5
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1L 8L6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X5A6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 1A5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ulm
State/Province
BW
ZIP/Postal Code
89081
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
BE10362
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bernau
ZIP/Postal Code
16321
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Pfizer Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Pfizer Investigational Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Pfizer Investigational Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Pfizer Investigational Site
City
Frankfurt
ZIP/Postal Code
HE 60528
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
D-22337
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Pfizer Investigational Site
City
AE Breda
ZIP/Postal Code
4836
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Blaricum
ZIP/Postal Code
1261 AN
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Ve Heeze
ZIP/Postal Code
5591
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Pfizer Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-826
Country
Poland
Facility Name
Pfizer Investigational Site
City
Choroszcz
ZIP/Postal Code
16-070
Country
Poland
Facility Name
Pfizer Investigational Site
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Pfizer Investigational Site
City
Gdansk
ZIP/Postal Code
82-803
Country
Poland
Facility Name
Pfizer Investigational Site
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Pfizer Investigational Site
City
Katowice
ZIP/Postal Code
46-645
Country
Poland
Facility Name
Pfizer Investigational Site
City
Krakow
ZIP/Postal Code
31-112
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Pfizer Investigational Site
City
Mosina
ZIP/Postal Code
62-050
Country
Poland
Facility Name
Pfizer Investigational Site
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
Pfizer Investigational Site
City
Plock
ZIP/Postal Code
09-402
Country
Poland
Facility Name
Pfizer Investigational Site
City
Poznan
ZIP/Postal Code
60-780
Country
Poland
Facility Name
Pfizer Investigational Site
City
Poznan
ZIP/Postal Code
61-285
Country
Poland
Facility Name
Pfizer Investigational Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warsaw
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
Country
Poland
Facility Name
Pfizer Investigational Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4099
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Pfizer Investigational Site
City
Granada
ZIP/Postal Code
18013
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Pfizer Investigational Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Pfizer Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Middlesborough
State/Province
N. York
ZIP/Postal Code
TS5 5AZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Washington
State/Province
Tyne & Wear
ZIP/Postal Code
NE38 9JZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Blackpool
ZIP/Postal Code
FY3 8BP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

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

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