Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy

April 10, 2019 updated by: Eisai Inc.

A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy

This study is conducted to assess the retention rate of Fycompa when given in routine clinical care.

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.

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.
2000

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Arizona Age Reversal & Neurology Clinic
      • Phoenix, Arizona, United States, 85006
        • Bronislava Shafran, MD, PC
      • Phoenix, Arizona, United States, 85013
        • Banner - University Medical Center Phoenix
      • Sun City, Arizona, United States, 85351
        • Arizona Neurological Institute
      • Tucson, Arizona, United States, 85724
        • The University of Arizona Department of Neurology
    • California
      • Madera, California, United States, 93636
        • Valley Children's Hospital
      • Sacramento, California, United States, 95814
        • UC Davis Medical Center
      • Sacramento, California, United States, 95816
        • Sutter Health
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Colorado Springs Neurological Associates
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Regional Hospital
      • Lakeland, Florida, United States, 33818
        • Capernaum Medical Center
      • Miami, Florida, United States, 33155
        • Nicklaus Children's Hospital
      • Orlando, Florida, United States, 32819
        • Pediatric Neurology PA
      • Orlando, Florida, United States, 32801
        • Nemours Children's Hospital
      • Sarasota, Florida, United States, 34239
        • Intercoastal Medical Group
      • Sarasota, Florida, United States, 34233
        • Doctors Hospital of Sarasota
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research
    • Idaho
      • Boise, Idaho, United States, 83702
        • Consultants in Epilepsy & Neurology PLLC
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Neurological Center
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Mid-Atlantic Epilepsy and Sleep Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Detroit, Michigan, United States, 48202
        • Spectrum Health System
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Medical Group
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • Minnesota Epilepsy Group
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Northeast Regional Epilepsy Group
    • New York
      • Hartsdale, New York, United States, 10530
        • ICAHN School of Medicine at Mount Sinai
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10075
        • Northwell Health
      • New York, New York, United States, 10003
        • Albert Einstein College of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Pennsylvania
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Le Bonheur Children's Hospital - PIN
    • Texas
      • Austin, Texas, United States, 78758
        • Austin Epilepsy Center
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston
    • Washington
      • Auburn, Washington, United States, 98001
        • Auburn Neurological Institute
      • Auburn, Washington, United States, 98002
        • Northwest Neurology & Electrodiagnostic Center
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital - PIN
      • Tacoma, Washington, United States, 98405-4048
        • MultiCare Institute for Research and Innovation

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Data will be obtained by reviewing the medical records of the participants with a diagnosis of epilepsy and treated with Fycompa on clinician's recommendation at up to approximately 40 epilepsy centers.

Description

Inclusion Criteria:

  • Participants must have met all of the following criteria to be included in this study:

    1. Diagnosis of epilepsy
    2. Initiated treatment with Fycompa at any time after 01 Jan 2014
    3. Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records (if required by an Institutional Review Board [IRB] or Independent Ethics Committee [IEC], or by regulatory authorities).

Exclusion Criteria:

  • Not applicable

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: Retrospective

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.
Fycompa
Participants diagnosed with epilepsy and treated with Fycompa
Drug: Fycompa
Oral suspension
Other Names:
  • Perampanel

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 remaining on Fycompa treatment at specified time points after initiation of treatment (Retention rate)
Time Frame: 3, 6, 12, 18, and 24 months
Retention rate is the ratio of the number of participants remaining on Fycompa treatment to the number of participants who could have been exposed for that length of time.
3, 6, 12, 18, and 24 months

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
Number of participants with a 50% response rate
Time Frame: up to 24 months
The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used.
up to 24 months
Number of participants with a 75% response rate
Time Frame: up to 24 months
The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used.
up to 24 months
Number of participants with a 100% response rate
Time Frame: up to 24 months
The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used.
up to 24 months
Categorized percent reduction in seizure frequency from baseline
Time Frame: Baseline, up to 24 months
An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure).
Baseline, up to 24 months
Median percent change in seizure frequency from baseline
Time Frame: Baseline, up to 24 months
An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure).
Baseline, up to 24 months
Percentage of participants who had no change or a worsening of seizures from baseline
Time Frame: Baseline, up to 24 months
An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure).
Baseline, up to 24 months
Total provider health care visits before, during, and after final dose of Fycompa
Time Frame: 6 months before initiation of Fycompa to 6 months after last dose of Fycompa
Total provider health care visits before, during, and after final dose of Fycompa will be summarized as a safety variable.
6 months before initiation of Fycompa to 6 months after last dose of Fycompa
Number of participants with any treatment-emergent (TE) serious adverse event (SAE) resulting in discontinuation of Fycompa
Time Frame: Up to 24 months
An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening (ie, the participant was at immediate risk of death from the adverse events [AE] as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.
Up to 24 months
Number of participants with any treatment-emergent adverse event (TEAE) resulting in discontinuation of Fycompa
Time Frame: Up to 24 months
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.
Up to 24 months
Mean change in body weight from baseline
Time Frame: Baseline, Up to 24 months
Change from baseline is calculated as the post-baseline value minus the baseline value.
Baseline, Up to 24 months
Mean change in height of pediatric participants from baseline
Time Frame: Baseline, Up to 24 months
Change from baseline is calculated as the post-baseline value minus the baseline value.
Baseline, Up to 24 months
Maximum dose of Fycompa
Time Frame: Up to 24 months
The extent of exposure of Fycompa will be determined by summarizing the maximum dose of the study drug.
Up to 24 months
Average dose of Fycompa
Time Frame: Up to 24 months
The extent of exposure of Fycompa will be determined by summarizing the average dose of the study drug.
Up to 24 months

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.
Eisai 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

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 (Actual)

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.
April 7, 2017

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.
March 15, 2019

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.
March 15, 2019

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).
July 3, 2017

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.
July 3, 2017

First Posted (Actual)

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.
July 5, 2017

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.
April 11, 2019

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.
April 10, 2019

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.
March 1, 2019

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.
  • E2007-G000-506

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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