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Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pregabalin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring open-label, extension study, pregabalin, partial epilepsy

Eligibility Criteria

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

Inclusion Criteria:

  • Completed the previous protocol and wish to continue to receive pregabalin.
  • Diagnosis of epilepsy with partial seizures

Exclusion Criteria:

  • Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Seizure Frequency
Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2008
Last Updated
January 22, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00596466
Brief Title
Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures
Official Title
An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (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
No

5. Study Description

Brief Summary
This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
open-label, extension study, pregabalin, partial epilepsy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
pregabalin
Primary Outcome Measure Information:
Title
Seizure Frequency
Time Frame
Baseline up to Week 28
Title
Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Time Frame
Baseline up to Week 28
Title
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Description
Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance.
Time Frame
Baseline up to Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed the previous protocol and wish to continue to receive pregabalin. Diagnosis of epilepsy with partial seizures Exclusion Criteria: Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.
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
Phoenix
State/Province
Arizona
ZIP/Postal Code
85003
Country
United States
Facility Name
Pfizer Investigational Site
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Pfizer Investigational Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Pfizer Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pfizer Investigational Site
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
Facility Name
Pfizer Investigational Site
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Pfizer Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Pfizer Investigational Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Pfizer Investigational Site
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Pfizer Investigational Site
City
Danville
State/Province
Indiana
ZIP/Postal Code
46122
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Pfizer Investigational Site
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Pfizer Investigational Site
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70363
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105-5634
Country
United States
Facility Name
Pfizer Investigational Site
City
Pikesville
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Pfizer Investigational Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
Pfizer Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Pfizer Investigational Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Pfizer Investigational Site
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Pfizer Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Pfizer Investigational Site
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Pfizer Investigational Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Pfizer Investigational Site
City
Beroun
ZIP/Postal Code
266 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Brno 2
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Litomysl
ZIP/Postal Code
570 14
Country
Czechia
Facility Name
Pfizer Investigational Site
City
New Territories
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49115
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Lugansk
ZIP/Postal Code
91045
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081160&StudyName=Extension%20Study%20Of%20Long-Term%20Safety%20And%20Efficacy%20Of%20Pregabalin%20As%20Monotherapy%20%28Lyrica%29%20In%20Patients%20With%20Partial%20Seizures
Description
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Learn more about this trial

Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures

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