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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00596466
First received: January 8, 2008
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Epilepsy
Drug: pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Seizure Frequency [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: No ]
  • Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline up to Week 28 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 75
Study Start Date: April 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: pregabalin
pregabalin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596466

  Hide Study Locations
Locations
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, 28209
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28203
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
Czech Republic
Pfizer Investigational Site
Beroun, Czech Republic, 266 01
Pfizer Investigational Site
Brno 2, Czech Republic, 602 00
Pfizer Investigational Site
Litomysl, Czech Republic, 570 14
Hong Kong
Pfizer Investigational Site
New Territories, Hong Kong
Ukraine
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49115
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49005
Pfizer Investigational Site
Kharkiv, Ukraine, 61068
Pfizer Investigational Site
Kharkiv, Ukraine, 61018
Pfizer Investigational Site
Lugansk, Ukraine, 91045
Pfizer Investigational Site
Odessa, Ukraine, 65025
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00596466     History of Changes
Other Study ID Numbers: A0081160
Study First Received: January 8, 2008
Results First Received: June 22, 2012
Last Updated: August 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
open-label
extension study
pregabalin
partial epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 22, 2014