Clinical Study With Lyrica In Patients Suffering From Epilepsy

January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce seizure frequency.

Study Overview

Status

Status

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

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

- Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).

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.
Observational

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.
286

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

  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Pfizer Investigational Site
      • Banska Bystrica, Slovakia, 97401
        • Pfizer Investigational Site
      • Bardejov, Slovakia, 08501
        • Pfizer Investigational Site
      • Bojnice, Slovakia, 97201
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 81369
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 83103
        • Pfizer Investigational Site
      • Bratislava 1, Slovakia, 80101
        • Pfizer Investigational Site
      • Bratislava 2, Slovakia, 82606
        • Pfizer Investigational Site
      • Bratislava 3, Slovakia, 83305
        • Pfizer Investigational Site
      • Bratislava 4, Slovakia, 84104
        • Pfizer Investigational Site
      • Cadca, Slovakia, 02201
        • Pfizer Investigational Site
      • Dolny Kubin, Slovakia, 02601
        • Pfizer Investigational Site
      • Dubnica nad Vahom, Slovakia, 1841
        • Pfizer Investigational Site
      • Dunajska Streda, Slovakia, 92901
        • Pfizer Investigational Site
      • Handlova, Slovakia, 97251
        • Pfizer Investigational Site
      • Hlohovec, Slovakia, 92001
        • Pfizer Investigational Site
      • Humenne, Slovakia, 06601
        • Pfizer Investigational Site
      • Kemarok, Slovakia, 06001
        • Pfizer Investigational Site
      • Komarno, Slovakia, 94501
        • Pfizer Investigational Site
      • Kosice, Slovakia, 04015
        • Pfizer Investigational Site
      • Kosice 1, Slovakia, 04001
        • Pfizer Investigational Site
      • Kosice 1, Slovakia, 04086
        • Pfizer Investigational Site
      • Kosice 2, Slovakia, 04011
        • Pfizer Investigational Site
      • Kosice 4, Slovakia, 04012
        • Pfizer Investigational Site
      • Kosice 4, Slovakia, 04190
        • Pfizer Investigational Site
      • Krompachy, Slovakia, 05342
        • Pfizer Investigational Site
      • Levice, Slovakia, 93401
        • Pfizer Investigational Site
      • Levoca, Slovakia, 05401
        • Pfizer Investigational Site
      • Liptovsky Mikulas, Slovakia, 03101
        • Pfizer Investigational Site
      • Malacky, Slovakia, 90122
        • Pfizer Investigational Site
      • Martin, Slovakia, 03601
        • Pfizer Investigational Site
      • Martin, Slovakia, 03659
        • Pfizer Investigational Site
      • Modra, Slovakia, 90001
        • Pfizer Investigational Site
      • Myjava, Slovakia, 90713
        • Pfizer Investigational Site
      • Nitra, Slovakia, 94901
        • Pfizer Investigational Site
      • Nove Mesto nad Vahom, Slovakia, 91501
        • Pfizer Investigational Site
      • Nove Zamky, Slovakia, 94034
        • Pfizer Investigational Site
      • Nove Zamky, Slovakia, 94073
        • Pfizer Investigational Site
      • Piestany, Slovakia, 92101
        • Pfizer Investigational Site
      • Poltar, Slovakia, 98701
        • Pfizer Investigational Site
      • Presov, Slovakia, 08001
        • Pfizer Investigational Site
      • Puchov, Slovakia, 2001
        • Pfizer Investigational Site
      • Ruzomberok, Slovakia, 03426
        • Pfizer Investigational Site
      • Ruzomberok, Slovakia, 03401
        • Pfizer Investigational Site
      • Sahy, Slovakia, 93601
        • Pfizer Investigational Site
      • Sered, Slovakia, 92601
        • Pfizer Investigational Site
      • Skalica, Slovakia, 90982
        • Pfizer Investigational Site
      • Snina, Slovakia, 06901
        • Pfizer Investigational Site
      • Spisska Nova Ves, Slovakia, 05201
        • Pfizer Investigational Site
      • Surany, Slovakia, 94218
        • Pfizer Investigational Site
      • Trebisov, Slovakia, 07501
        • Pfizer Investigational Site
      • Trencin, Slovakia, 91101
        • Pfizer Investigational Site
      • Trnava, Slovakia, 91701
        • Pfizer Investigational Site
      • Trnava, Slovakia, 91775
        • Pfizer Investigational Site
      • Trstena, Slovakia, 02801
        • Pfizer Investigational Site
      • Vranov Nad Toplov, Slovakia, 09327
        • Pfizer Investigational Site
      • Zilina, Slovakia, 012 07
        • Pfizer Investigational Site
      • Zilina, Slovakia, 01001
        • Pfizer Investigational Site
      • Zlate Moravce, Slovakia, 95301
        • Pfizer Investigational Site
      • Zvolen, Slovakia, 86001
        • Pfizer Investigational Site
      • Zvolen, Slovakia, 96001
        • 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

Sampling Method

Probability Sample

Study Population

  • Adult patiens with partial seizures.
  • Other inclusion criteria according to Summary of Product Characteristics (SmPC).

Description

Inclusion Criteria:

  • Adult patients with partial seizures.

Exclusion Criteria:

  • Contraindications according to Summary of Product Characteristics (SmPC).

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Lyrica
Adult patients with partial seizures (type of epilepsy). Inclusion criteria according to Summary of Product Characteristics
Drug: Lyrica (pregabalin)
The daily dose may range from 150mg to 600mg, administered as two single doses. The treatment should be started with 150mg daily dose (2x75mg). Depending on response and tolerability after 7 days may the dose be increased to 300mg/day (2x150mg) and after further 7 days to maximum dose 600mg/day (2x300mg)

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 With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency
Time Frame: Baseline through week 16 or early termination (ET)
Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency * 100, divided by the partial seizure frequency at the baseline visit.
Baseline through week 16 or early termination (ET)

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 Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit
Time Frame: Baseline and week 16 or ET
The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant's final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit * 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency*100 divided by partial seizure frequency at baseline visit.
Baseline and week 16 or ET
Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study
Time Frame: Week 4 through week 16 or ET
Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study.
Week 4 through week 16 or ET
Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit
Time Frame: Baseline, week 4 and week 16 or ET
VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).
Baseline, week 4 and week 16 or ET
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Time Frame: Baseline
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Baseline
Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit
Time Frame: Week 16 or ET

The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C).

At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse.
Week 16 or ET
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET
Time Frame: Baseline and week 16 or ET
MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute.
Baseline and week 16 or ET

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Concomitant Drug Treatments
Time Frame: Baseline through Week 16 or ET
Concomitant drug (any drug other than, and in addition to, the study drug) taken for any period of time during the study.
Baseline through Week 16 or ET
Number of Participants With Concomitant Co-morbidities
Time Frame: Baseline through week 16 or ET
Participants who had a concomitant co-morbidity during the study for any period of time from baseline through to Week 16 (Final Visit); participants with more than one concomitant co-morbidity were counted for each of the co-morbidity classes applicable.
Baseline through week 16 or ET

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.

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, 2009

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.
June 1, 2010

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, 2010

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).
June 17, 2009

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.
June 17, 2009

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.
June 18, 2009

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 25, 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 21, 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.
July 1, 2011

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.
  • A0081236

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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