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

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ClinicalTrials.gov Identifier: NCT00596466
Recruitment Status : Completed
First Posted : January 17, 2008
Results First Posted : September 11, 2012
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: pregabalin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Pregabalin

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: pregabalin
pregabalin


Outcome Measures
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Primary Outcome Measures :
  1. Seizure Frequency [ Time Frame: Baseline up to Week 28 ]
  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596466


Locations
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United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85003
United States, Arkansas
Pfizer Investigational Site
Fayetteville, Arkansas, United States, 72703
United States, California
Pfizer Investigational Site
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
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80204
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32209
United States, Georgia
Pfizer Investigational Site
Suwanee, Georgia, United States, 30024
United States, Indiana
Pfizer Investigational Site
Danville, Indiana, United States, 46122
Pfizer Investigational Site
Fort Wayne, Indiana, United States, 46805
United States, Kansas
Pfizer Investigational Site
Kansas City, Kansas, United States, 66160
United States, Kentucky
Pfizer Investigational Site
Bowling Green, Kentucky, United States, 42101
Pfizer Investigational Site
Lexington, Kentucky, United States, 40536
United States, Louisiana
Pfizer Investigational Site
Houma, Louisiana, United States, 70363
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71105-5634
United States, Maryland
Pfizer Investigational Site
Pikesville, Maryland, United States, 21208
United States, Massachusetts
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01608
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48202
United States, Mississippi
Pfizer Investigational Site
Flowood, Mississippi, United States, 39232
United States, Montana
Pfizer Investigational Site
Great Falls, Montana, United States, 59405
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28203
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28209
United States, Ohio
Pfizer Investigational Site
Columbus, Ohio, United States, 43210
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73120
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
Houston, Texas, United States, 77074
Pfizer Investigational Site
Temple, Texas, United States, 76508
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84107
Pfizer Investigational Site
West Jordan, Utah, United States, 84088
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53226
Czechia
Pfizer Investigational Site
Beroun, Czechia, 266 01
Pfizer Investigational Site
Brno 2, Czechia, 602 00
Pfizer Investigational Site
Litomysl, Czechia, 570 14
Hong Kong
Pfizer Investigational Site
New Territories, Hong Kong
Ukraine
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49005
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49115
Pfizer Investigational Site
Kharkiv, Ukraine, 61018
Pfizer Investigational Site
Kharkiv, Ukraine, 61068
Pfizer Investigational Site
Lugansk, Ukraine, 91045
Pfizer Investigational Site
Odessa, Ukraine, 65025
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00596466    
Other Study ID Numbers: A0081160
First Posted: January 17, 2008    Key Record Dates
Results First Posted: September 11, 2012
Last Update Posted: January 26, 2021
Last Verified: August 2012
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
open-label
extension study
pregabalin
partial epilepsy
Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs