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Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

Primary Purpose

Epilepsies, Partial, Epilepsy, Complex 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 Epilepsies, Partial

Eligibility Criteria

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

Inclusion Criteria: Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening Be currently taking 1 to 3 AEDs. Exclusion Criteria: Have a treatable cause of seizures Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication

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
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Safety assessments are performed at quarterly visits up until the study is closed.

Secondary Outcome Measures

Seizure frequency is assessed throughout the study until the study is closed.

Full Information

First Posted
August 30, 2005
Last Updated
July 21, 2006
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00143143
Brief Title
Pregabalin Open-Label Extension Trial in Patients With Partial Seizures
Official Title
Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
The primary purpose of the protocol is to evaluate the long-term safety 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
Epilepsies, Partial, Epilepsy, Complex 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
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pregabalin
Primary Outcome Measure Information:
Title
Safety assessments are performed at quarterly visits up until the study is closed.
Secondary Outcome Measure Information:
Title
Seizure frequency is assessed throughout the study until the study is closed.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have met the inclusion criteria for Study 1008-157, have received double-blind study medication, and wish to receive open-label pregabalin Have the diagnosis of epilepsy with partial seizures and have a minimum of 4 partial seizures during the 6 weeks prior to screening Be currently taking 1 to 3 AEDs. Exclusion Criteria: Have a treatable cause of seizures Experienced a serious adverse event during Study 1008-157 which was determined to be possibly related to study medication
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
Innsbruck
ZIP/Postal Code
A6020
Country
Austria
Facility Name
Pfizer Investigational Site
City
Mauer Bei Amstetten
ZIP/Postal Code
3362
Country
Austria
Facility Name
Pfizer Investigational Site
City
St Polten
ZIP/Postal Code
A3100
Country
Austria
Facility Name
Pfizer Investigational Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
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
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
K1H 8L6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Trois Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 4K4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Marseille
State/Province
Cedex 05
ZIP/Postal Code
13005
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
State/Province
Cedex 13
ZIP/Postal Code
75651
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
Lille
State/Province
Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Pfizer Investigational Site
City
Rennes
State/Province
Cedex
ZIP/Postal Code
35033
Country
France
Facility Name
Pfizer Investigational Site
City
Colomiers
ZIP/Postal Code
31770
Country
France
Facility Name
Pfizer Investigational Site
City
Dommartin Les Toul
ZIP/Postal Code
54201
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille Cedex 09
ZIP/Postal Code
13274
Country
France
Facility Name
Pfizer Investigational Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bonn
ZIP/Postal Code
53127
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
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
Kehl
ZIP/Postal Code
77694
Country
Germany
Facility Name
Pfizer Investigational Site
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Pfizer Investigational Site
City
ULM
ZIP/Postal Code
89075
Country
Germany
Facility Name
Pfizer Investigational Site
City
Firenze
ZIP/Postal Code
50122
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
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
2600
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
LT-2600
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Donostia-San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Gerona
ZIP/Postal Code
17007
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
Glascow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Fazakerley, Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
York
ZIP/Postal Code
Y031 8HE
Country
United Kingdom
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

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Pregabalin Open-Label Extension Trial in Patients With Partial Seizures

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