NCT00141388

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
455

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_3

Geographic Reach
2 countries

56 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

November 6, 2009

Status Verified

November 1, 2009

First QC Date

August 30, 2005

Last Update Submit

November 5, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • Safety Efficacy

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have received double-blind study medication and wish to receive open-label pregabalin.

You may not qualify if:

  • Cannot have absence seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (56)

Pfizer Investigational Site

Birmingham, Alabama, 35249, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35255, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35294-0021, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85006, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85712-2809, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85712, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90033, United States

Location

Pfizer Investigational Site

Pasadena, California, 91105, United States

Location

Pfizer Investigational Site

Gainesville, Florida, 32608-1197, United States

Location

Pfizer Investigational Site

Gainesville, Florida, 32610, United States

Location

Pfizer Investigational Site

Miami, Florida, 33136, United States

Location

Pfizer Investigational Site

Plantation, Florida, 33317, United States

Location

Pfizer Investigational Site

Spring Hill, Florida, 34609, United States

Location

Pfizer Investigational Site

Tallahassee, Florida, 32308, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60612, United States

Location

Pfizer Investigational Site

Springfield, Illinois, 62702, United States

Location

Pfizer Investigational Site

Springfield, Illinois, 62704, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46254, United States

Location

Pfizer Investigational Site

Iowa City, Iowa, 52242, United States

Location

Pfizer Investigational Site

Kansas City, Kansas, 66160-7314, United States

Location

Pfizer Investigational Site

Kansas City, Kansas, 66160, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40205, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21201, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21224, United States

Location

Pfizer Investigational Site

Greenbelt, Maryland, 20770, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02130, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48108, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Pfizer Investigational Site

Saint Paul, Minnesota, 55102, United States

Location

Pfizer Investigational Site

Chesterfield, Missouri, 63017, United States

Location

Pfizer Investigational Site

Columbia, Missouri, 65212, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110-1092, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

Lebanon, New Hampshire, 03756, United States

Location

Pfizer Investigational Site

New York, New York, 10016, United States

Location

Pfizer Investigational Site

New York, New York, 10032, United States

Location

Pfizer Investigational Site

Rochester, New York, 14642, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27157, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43210, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97227, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Bennington, Vermont, 05201, United States

Location

Pfizer Investigational Site

Edmonton, Alberta, T5H 3V9, Canada

Location

Pfizer Investigational Site

Edmont, Alberta, T5G 0B7, Canada

Location

Pfizer Investigational Site

Vancouver, British Columbia, V52 1M9, Canada

Location

Pfizer Investigational Site

Vancouver, British Columbia, V67 1Y6, Canada

Location

Pfizer Investigational Site

London, Ontario, N6A 5A5, Canada

Location

Pfizer Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M4Y 1J3, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3A 2B4, Canada

Location

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

July 1, 1998

Study Completion

October 1, 2005

Last Updated

November 6, 2009

Record last verified: 2009-11

Locations