NCT00596466

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2008

Typical duration for phase_3

Geographic Reach
4 countries

44 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

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 11, 2012

Completed
Last Updated

January 26, 2021

Status Verified

August 1, 2012

Enrollment Period

3.7 years

First QC Date

January 8, 2008

Results QC Date

June 22, 2012

Last Update Submit

January 22, 2021

Conditions

Epilepsy

Keywords

open-labelextension studypregabalinpartial epilepsy

Outcome Measures

Primary Outcomes (3)

  • Seizure Frequency

    Baseline up to Week 28

  • Number of Participants With (All Causality) Adverse Events (AEs) and Serious Adverse Events (SAEs)

    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.

    Baseline up to Week 28

  • Number of Participants With Laboratory Test Values of Potential Clinical Importance

    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.

    Baseline up to Week 28

Study Arms (1)

1

EXPERIMENTAL
Drug: pregabalin

Interventions

pregabalinDRUG

pregabalin

1

Eligibility Criteria

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

You may qualify if:

  • Completed the previous protocol and wish to continue to receive pregabalin.
  • Diagnosis of epilepsy with partial seizures

You may not qualify if:

  • Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (44)

Pfizer Investigational Site

Phoenix, Arizona, 85003, United States

Location

Pfizer Investigational Site

Fayetteville, Arkansas, 72703, United States

Location

Pfizer Investigational Site

Fullerton, California, 92835, United States

Location

Pfizer Investigational Site

Long Beach, California, 90806, United States

Location

Pfizer Investigational Site

Modesto, California, 95355, United States

Location

Pfizer Investigational Site

Murrieta, California, 92562, United States

Location

Pfizer Investigational Site

Newport Beach, California, 92660, United States

Location

Pfizer Investigational Site

Temecula, California, 92591, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80204, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32209, United States

Location

Pfizer Investigational Site

Suwanee, Georgia, 30024, United States

Location

Pfizer Investigational Site

Danville, Indiana, 46122, United States

Location

Pfizer Investigational Site

Fort Wayne, Indiana, 46805, United States

Location

Pfizer Investigational Site

Kansas City, Kansas, 66160, United States

Location

Pfizer Investigational Site

Bowling Green, Kentucky, 42101, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40536, United States

Location

Pfizer Investigational Site

Houma, Louisiana, 70363, United States

Location

Pfizer Investigational Site

Shreveport, Louisiana, 71105-5634, United States

Location

Pfizer Investigational Site

Pikesville, Maryland, 21208, United States

Location

Pfizer Investigational Site

Worcester, Massachusetts, 01608, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48202, United States

Location

Pfizer Investigational Site

Flowood, Mississippi, 39232, United States

Location

Pfizer Investigational Site

Great Falls, Montana, 59405, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28203, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28209, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43210, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73120, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

Houston, Texas, 77074, United States

Location

Pfizer Investigational Site

Temple, Texas, 76508, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84107, United States

Location

Pfizer Investigational Site

West Jordan, Utah, 84088, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53226, United States

Location

Pfizer Investigational Site

Beroun, 266 01, Czechia

Location

Pfizer Investigational Site

Brno, 602 00, Czechia

Location

Pfizer Investigational Site

Litomyšl, 570 14, Czechia

Location

Pfizer Investigational Site

New Territories, Hong Kong

Location

Pfizer Investigational Site

Dnipropetrovsk, 49005, Ukraine

Location

Pfizer Investigational Site

Dnipropetrovsk, 49115, Ukraine

Location

Pfizer Investigational Site

Kharkiv, 61018, Ukraine

Location

Pfizer Investigational Site

Kharkiv, 61068, Ukraine

Location

Pfizer Investigational Site

Luhansk, 91045, Ukraine

Location

Pfizer Investigational Site

Odesa, 65025, Ukraine

Location

MeSH Terms

Conditions

EpilepsyEpilepsies, Partial

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 17, 2008

Study Start

April 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 26, 2021

Results First Posted

September 11, 2012

Record last verified: 2012-08

Locations

UA(6)US(34)CZ(3)HK(1)