NCT00141414

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 1997

Longer than P75 for phase_2

Geographic Reach
2 countries

25 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

November 1, 1997

Completed
7.8 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

January 1, 2007

Status Verified

December 1, 2006

First QC Date

August 30, 2005

Last Update Submit

December 28, 2006

Conditions

Epilepsy, Partial

Outcome Measures

Primary Outcomes (1)

  • Safety

Interventions

PregabalinDRUG

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:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90033, United States

Location

Pfizer Investigational Site

Stanford, California, 94305, United States

Location

Pfizer Investigational Site

Miami, Florida, 33136, United States

Location

Pfizer Investigational Site

Plantation, Florida, 33317, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46254, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21201, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21287, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48108-0768, 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

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

The Bronx, New York, 10467, 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

Philadelphia, Pennsylvania, 19104, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53715, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53792, United States

Location

Pfizer Investigational Site

Bonn, 53105, Germany

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 2
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

November 1, 1997

Study Completion

October 1, 2005

Last Updated

January 1, 2007

Record last verified: 2006-12

Locations

DE(1)US(24)