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

January 15, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on September 7, 2011.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Beroun, Czechia, 266 01
        • Pfizer Investigational Site
      • Brno 2, Czechia, 602 00
        • Pfizer Investigational Site
      • Litomysl, Czechia, 570 14
        • Pfizer Investigational Site
  • Hong Kong
      • New Territories, Hong Kong
        • Pfizer Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49115
        • Pfizer Investigational Site
      • Dnipropetrovsk, Ukraine, 49027
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61068
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61018
        • Pfizer Investigational Site
      • Lugansk, Ukraine, 91045
        • Pfizer Investigational Site
      • Odessa, Ukraine, 65025
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Northport, Alabama, United States, 35476
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85003
        • Pfizer Investigational Site
      • Sun City, Arizona, United States, 85351
        • Pfizer Investigational Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Pfizer Investigational Site
    • California
      • Fullerton, California, United States, 92835
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90806
        • Pfizer Investigational Site
      • Modesto, California, United States, 95355
        • Pfizer Investigational Site
      • Murrieta, California, United States, 92562
        • Pfizer Investigational Site
      • Newport Beach, California, United States, 92660
        • Pfizer Investigational Site
      • Temecula, California, United States, 92591
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80204
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Pfizer Investigational Site
      • Melbourne, Florida, United States, 32901
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33126
        • Pfizer Investigational Site
      • Sarasota, Florida, United States, 34233
        • Pfizer Investigational Site
      • Sarasota, Florida, United States, 34232
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30309
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Lawrenceville, Georgia, United States, 30045
        • Pfizer Investigational Site
      • Suwanee, Georgia, United States, 30024
        • Pfizer Investigational Site
    • Indiana
      • Anderson, Indiana, United States, 46016
        • Pfizer Investigational Site
      • Danville, Indiana, United States, 46122
        • Pfizer Investigational Site
      • Fort Wayne, Indiana, United States, 46805
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Pfizer Investigational Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Pfizer Investigational Site
      • Lexington, Kentucky, United States, 40536
        • Pfizer Investigational Site
      • Lexington, Kentucky, United States, 40536-0284
        • Pfizer Investigational Site
    • Louisiana
      • Houma, Louisiana, United States, 70363
        • Pfizer Investigational Site
      • Shreveport, Louisiana, United States, 71105-5634
        • Pfizer Investigational Site
    • Maryland
      • Pikesville, Maryland, United States, 21208
        • Pfizer Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Pfizer Investigational Site
      • Worcester, Massachusetts, United States, 01608
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55422
        • Pfizer Investigational Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Pfizer Investigational Site
      • Hattiesburg, Mississippi, United States, 39401-7246
        • Pfizer Investigational Site
    • Montana
      • Great Falls, Montana, United States, 59405
        • Pfizer Investigational Site
    • New York
      • Cedarhurst, New York, United States, 11516
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28209
        • Pfizer Investigational Site
      • Rocky Mount, North Carolina, United States, 27804
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43210
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43210-1250
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73120
        • Pfizer Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Pfizer Investigational Site
      • Indiana, Pennsylvania, United States, 15701
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38163
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37232
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77074-2906
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78258
        • Pfizer Investigational Site
      • Temple, Texas, United States, 76508
        • Pfizer Investigational Site
    • Utah
      • Murray, Utah, United States, 84107
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84107
        • Pfizer Investigational Site
      • West Jordan, Utah, United States, 84088
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of epilepsy with partial seizures.
  • Males or females, age 18 years or older.
  • Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit.
  • Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit.

Exclusion Criteria:

  • Current diagnosis of febrile seizures or seizures related to an ongoing acute medical event.
  • Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin.
  • Primary generalized epilepsy or status epilepticus within the previous year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: pregabalin 600 mg/day
pregabalin 600 mg/day (300mg BID), duration is 20 weeks.
Experimental: 2
Drug: pregabalin 150 mg/day
pregabalin 150 mg/day (75mg BID), duration is 20 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants in the Pregabalin 600 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria
Time Frame: Week 2 up to Week 18
Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier [KM] product limit estimate for survival function) * 100%
Week 2 up to Week 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants in the Pregabalin 150 mg/Day Treatment Group Discontinuing the Study Due to at Least 1 Pre-Defined Seizure Exit Criteria
Time Frame: Week 2 up to Week 18
Participants who discontinued due to: episode of SE; SGTC seizure if none within 2 years of study entry; 28-day study seizure rate during DBP >2 times Max 28-day study seizure rate during BLP; 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate, defined as (1-KM product limit estimate for survival function) * 100%
Week 2 up to Week 18
Percentage of Participants Completing 20 Weeks of Double-Blind Treatment
Time Frame: Randomization up to Week 20
Randomization up to Week 20
Percentage of Participants Who Met Protocol-Specified Exit Events
Time Frame: Week 2 up to Week 18
Percentage of participants experiencing any of the following (could have had more than 1): 1) episode of SE; 2) SGTC seizure if none had been experienced within 2 years of study entry; 3) 28-day study seizure rate during DBP >2 times the Max 28-day study seizure rate during BLP; 4) 2-day study seizure rate during the DBP >2 times the Max 2-day study seizure rate during BLP; or 5) unacceptable clinically significant increase in frequency/intensity of seizure activity
Week 2 up to Week 18
Mean Time on Pregabalin Monotherapy
Time Frame: Week 2 to Week 20
Week 2 to Week 20
Percentage of Seizure-Free Participants by Study Phase
Time Frame: Day 1 up to Day 140
Percentage of participants who were seizure-free during the last 28 days on double-blind study medication (monotherapy phase, Days 112-140), during the monotherapy portion of the double-blind treatment phase (Days 56-140), and during all of the double-blind treatment phase (Days 1-140)
Day 1 up to Day 140
Pregabalin Population Pharmacokinetics (PK)
Time Frame: Baseline up to 20 weeks
Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Baseline up to 20 weeks
Pregabalin Exposure-Response Analysis
Time Frame: Day 126
Percentage of participants predicted to exit the study due to any seizure exit criteria at Day 126. The exit rate at Day 126 was predicted using the final model (log normal distribution with respect to treatment group) and the parameter estimates.
Day 126

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

August 30, 2007

First Submitted That Met QC Criteria

August 30, 2007

First Posted (Estimate)

September 3, 2007

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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