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To Evaluate the Long-Term Safety of Pregabalin in Refractory Partial Epilepsy.

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ClinicalTrials.gov Identifier: NCT00141414
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : January 1, 2007
Sponsor:
Information provided by:
Pfizer

Brief Summary:
To evaluate the long-term safety of pregabalin in refractory partial epilepsy.

Condition or disease Intervention/treatment Phase
Epilepsy, Partial Drug: Pregabalin Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pregabablin Open-Label, Follow-On Safety Trial In Patients With Refractory Partial Epilepsy.
Study Start Date : November 1997
Study Completion Date : October 2005





Primary Outcome Measures :
  1. Safety


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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:

  • Must have met the inclusion criteria for preceding double-blind study.
  • Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

  • Pregnant or considering becoming pregnant.
  • Receiving any concomitant medication that could alter the effectiveness of their medication response or seizure frequency.

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): NCT00141414


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Locations
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90033
Pfizer Investigational Site
Stanford, California, United States, 94305
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33136
Pfizer Investigational Site
Plantation, Florida, United States, 33317
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46254
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21201
Pfizer Investigational Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48108-0768
United States, Minnesota
Pfizer Investigational Site
St. Paul, Minnesota, United States, 55102
United States, Missouri
Pfizer Investigational Site
Chesterfield, Missouri, United States, 63017
United States, New York
Pfizer Investigational Site
Bronx, New York, United States, 10467
Pfizer Investigational Site
New York, New York, United States, 10016
Pfizer Investigational Site
New York, New York, United States, 10032
Pfizer Investigational Site
Rochester, New York, United States, 14642
United States, North Carolina
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
Pfizer Investigational Site
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53715
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792
Germany
Pfizer Investigational Site
Bonn, Germany, 53105
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

ClinicalTrials.gov Identifier: NCT00141414     History of Changes
Other Study ID Numbers: 1008-008
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: January 1, 2007
Last Verified: December 2006

Additional relevant MeSH terms:
Epilepsies, Partial
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs