To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

Seizure Disorder, Partial Clinical Trial

Official title:

Pregabalin BID Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141336
• Other study ID #: 1008-035
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2005
• Last updated: December 28, 2006
• Start date: November 1999
• Est. completion date: July 2005

Study information

• Verified date: December 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the long-term safety and tolerability of pregabalin in patients with partial seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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:

• Cannot have absence seizures

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Seizure Disorder, Partial
• Seizures

Intervention

Drug:
• Pregabalin

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Barrie	Ontario
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Alexandria	Virginia
United States	Pfizer Investigational Site	Alexandria	Virginia
United States	Pfizer Investigational Site	Asheville	North Carolina
United States	Pfizer Investigational Site	Asheville	North Carolina
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Bakersfield	California
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bellevue	Washington
United States	Pfizer Investigational Site	Bellvue	Washington
United States	Pfizer Investigational Site	Berkeley	California
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Charlottesville	Virginia
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Concord	New Hampshire
United States	Pfizer Investigational Site	Concord	California
United States	Pfizer Investigational Site	Covina	California
United States	Pfizer Investigational Site	Cranston	Rhode Island
United States	Pfizer Investigational Site	Crestview Hills	Kentucky
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Danbury	Connecticut
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Dover	New Hampshire
United States	Pfizer Investigational Site	El Cajon	California
United States	Pfizer Investigational Site	Encino	California
United States	Pfizer Investigational Site	Englewood	Colorado
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Golden Valley	Minnesota
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Jackson	Mississippi
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	La Mesa	California
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Lubbock	Texas
United States	Pfizer Investigational Site	Marina del Ray	California
United States	Pfizer Investigational Site	Marshfield	Wisconsin
United States	Pfizer Investigational Site	Martinez	California
United States	Pfizer Investigational Site	Medford	Oregon
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Morgantown	West Virginia
United States	Pfizer Investigational Site	New Brunswick	New Jersey
United States	Pfizer Investigational Site	New Brunswick	New Jersey
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Northridge	California
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Pinole	California
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Redondo Beach	California
United States	Pfizer Investigational Site	Ridgewood	New Jersey
United States	Pfizer Investigational Site	Ridley Park	Pennsylvania
United States	Pfizer Investigational Site	Roanoke	Virginia
United States	Pfizer Investigational Site	Roanoke	Virginia
United States	Pfizer Investigational Site	Ruston	Louisiana
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Santa Monica	California
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Sterling	Virginia
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Upland	Pennsylvania
United States	Pfizer Investigational Site	Walnut Creek	California
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Tolerability