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

January 22, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Beroun, Czechia, 266 01
        • Pfizer Investigational Site
      • Brno 2, Czechia, 602 00
        • Pfizer Investigational Site
      • Litomysl, Czechia, 570 14
        • Pfizer Investigational Site
  • Hong Kong
      • New Territories, Hong Kong
        • Pfizer Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
        • Pfizer Investigational Site
      • Dnipropetrovsk, Ukraine, 49115
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61068
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61018
        • Pfizer Investigational Site
      • Lugansk, Ukraine, 91045
        • Pfizer Investigational Site
      • Odessa, Ukraine, 65025
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85003
        • Pfizer Investigational Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Pfizer Investigational Site
    • California
      • Fullerton, California, United States, 92835
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90806
        • Pfizer Investigational Site
      • Modesto, California, United States, 95355
        • Pfizer Investigational Site
      • Murrieta, California, United States, 92562
        • Pfizer Investigational Site
      • Newport Beach, California, United States, 92660
        • Pfizer Investigational Site
      • Temecula, California, United States, 92591
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80204
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Pfizer Investigational Site
    • Georgia
      • Suwanee, Georgia, United States, 30024
        • Pfizer Investigational Site
    • Indiana
      • Danville, Indiana, United States, 46122
        • Pfizer Investigational Site
      • Fort Wayne, Indiana, United States, 46805
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Pfizer Investigational Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Pfizer Investigational Site
      • Lexington, Kentucky, United States, 40536
        • Pfizer Investigational Site
    • Louisiana
      • Houma, Louisiana, United States, 70363
        • Pfizer Investigational Site
      • Shreveport, Louisiana, United States, 71105-5634
        • Pfizer Investigational Site
    • Maryland
      • Pikesville, Maryland, United States, 21208
        • Pfizer Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Pfizer Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Pfizer Investigational Site
    • Montana
      • Great Falls, Montana, United States, 59405
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28209
        • Pfizer Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73120
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77074
        • Pfizer Investigational Site
      • Temple, Texas, United States, 76508
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Pfizer Investigational Site
      • West Jordan, Utah, United States, 84088
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: pregabalin
pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure Frequency
Time Frame: Baseline up to Week 28
Baseline up to Week 28
Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to Week 28
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.
Baseline up to Week 28
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Time Frame: Baseline up to Week 28
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.
Baseline up to Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 8, 2008

First Posted (Estimate)

January 17, 2008

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081160

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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