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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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