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Extension Study Of Long-Term Safety And Efficacy Of Pregabalin As Monotherapy (Lyrica) In Patients With Partial Seizures

NCT ID: NCT00596466

Last Updated: 2021-01-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

pregabalin

Intervention Type DRUG

pregabalin

Interventions

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pregabalin

pregabalin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Early withdrawal from the previous protocol, an episode of status epliepticus, or primary generalized epilepsy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

Fayetteville, Arkansas, United States

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Fullerton, California, United States

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Long Beach, California, United States

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Modesto, California, United States

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Murrieta, California, United States

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Newport Beach, California, United States

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Temecula, California, United States

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Denver, Colorado, United States

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Jacksonville, Florida, United States

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Suwanee, Georgia, United States

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Danville, Indiana, United States

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Fort Wayne, Indiana, United States

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Kansas City, Kansas, United States

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Bowling Green, Kentucky, United States

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Lexington, Kentucky, United States

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Houma, Louisiana, United States

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Shreveport, Louisiana, United States

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Pikesville, Maryland, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Flowood, Mississippi, United States

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Great Falls, Montana, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Temple, Texas, United States

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Salt Lake City, Utah, United States

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West Jordan, Utah, United States

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Milwaukee, Wisconsin, United States

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Pfizer Investigational Site

Beroun, , Czechia

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Pfizer Investigational Site

Brno, , Czechia

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Pfizer Investigational Site

Litomyšl, , Czechia

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Pfizer Investigational Site

New Territories, , Hong Kong

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Pfizer Investigational Site

Dnipropetrovsk, , Ukraine

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Pfizer Investigational Site

Dnipropetrovsk, , Ukraine

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Pfizer Investigational Site

Kharkiv, , Ukraine

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Pfizer Investigational Site

Kharkiv, , Ukraine

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Pfizer Investigational Site

Luhansk, , Ukraine

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Pfizer Investigational Site

Odesa, , Ukraine

Site Status

Countries

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United States Czechia Hong Kong Ukraine

Other Identifiers

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A0081160

Identifier Type: -

Identifier Source: org_study_id

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