A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years

September 6, 2018 updated by: Eisai Inc.
The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.

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

This is a global, observational, cohort study in patients with epilepsy. Multiple treating physicians will prescribe perampanel to approximately 500 patients, who then will be observed for approximately 52 weeks.

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.
500

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

  • Austria
      • Innsbruck, Austria, 6020
        • Universitätsklinikum Innsbruck
      • Linz, Austria, 4020
        • Kepler Universitätsklinikum
      • Wien, Austria, 1130
        • Krankenhaus Wien-Hietzing
  • Belgium
      • Battice, Belgium
        • Eisai Site# 2405
      • Bruxelles, Belgium, 1070
        • Hôpital Erasme
      • Bruxelles, Belgium
        • Eisai Site# 2404
      • Duffel, Belgium
        • Eisai Site# 2406
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium
        • Eisai Site# 2409
      • Ottignies, Belgium
        • Eisai Site# 2403
      • Ruddershove, Belgium
        • Eisai Site# 2408
      • Woluwe-Saint-Lambert, Belgium
        • Eisai Site# 2407
      • Yvoir, Belgium
        • Eisai Site# 2402
  • Czechia
      • Beroun, Czechia
        • Eisai Site# 2601
      • Brno, Czechia
        • Eisai Site# 2600
      • Hradec Králové, Czechia
        • Eisai Site# 2606
      • Náchod, Czechia
        • Eisai Site# 2602
      • Ostrava, Czechia, 72200
        • Cerebrovaskularni poradna s.r.o.
      • Praha, Czechia
        • Eisai Site# 2603
  • Israel
      • Be'er Sheva, Israel
        • Eisai Site# 2013
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • H̱olon, Israel, 58100
        • Edith Wolfson Medical Center
      • Jerusalem, Israel
        • Kiryat Hadassah
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Nahariya, Israel, 22100
        • Western Galilee Hospital
      • Petach Tikva, Israel, 49202
        • Schneider Children's Medical Center of Israel
      • Ramat Gan, Israel
        • The Chaim Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center
      • Tel Aviv-Yafo, Israel
        • Eisai Site# 2003
      • Tel Aviv-Yafo, Israel
        • Eisai Site# 2012
      • Tel-Hashomer, Israel
        • Eisai Site# 2008
  • Sweden
      • Göteborg, Sweden, SE-41345
        • Sahlgrenska Universitetssjukhuset
      • Linköping, Sweden, 58185
        • Universitetssjukhuset i Linköping
  • United Kingdom
      • Bristol, United Kingdom
        • Eisai Site# 1607
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Lincoln, United Kingdom
        • Eisai Site# 1611
      • London, United Kingdom
        • Great Ormond Street Hospital
      • London, United Kingdom
        • Eisai Site# 1604
      • London, United Kingdom
        • Eisai Site# 1608
      • London, United Kingdom
        • Eisai Site# 1609
      • Newcastle, United Kingdom
        • Eisai Site# 1612
      • Truro, United Kingdom
        • Eisai Site# 1606

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Epilepsy patients prescribed adjunctive treatment in countries where perampanel has received marketing approval. Multiple treating physicians will prescribe perampanel to patients, who then will be observed for approximately 52 weeks.

Description

Inclusion Criteria

  1. Male or female patients age greater than or equal to 12 years (or as regionally appropriate) at the time of informed consent
  2. Patients prescribed perampanel for the adjunctive treatment of epilepsy within 7 days of the Screening Visit
  3. Patients who provide informed consent

Exclusion Criteria

  1. Participation in another study involving administration of an investigational drug or device whilst participating in this observational study
  2. Prior participation in a perampanel clinical study
  3. Hypersensitivity to perampanel

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

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.
Perampanel
Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment
Drug: Perampanel
Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment

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
Number of Treatment Emergent Adverse Events (TEAEs) of interest
Time Frame: Up to 52 weeks and 2 weeks of follow-up
Assessment of events of dizziness, blurred vision, somnolence, aggression, balance disorders, ataxia, falls, unintended pregnancy, weight gain, suicidality, drug abuse, misuse, dependence, withdrawal, off-label use, skin photosensitivity, unintended pregnancy while taking levonorgestrel-containing contraceptives, and outcomes associated with any suspected drug-drug interaction.
Up to 52 weeks and 2 weeks of follow-up

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
Incidence of unintended pregnancy
Time Frame: Up to 52 weeks
Up to 52 weeks
Incidence of off-label use
Time Frame: Up to 52 weeks
Up to 52 weeks
Summary scores for the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Screening, Week 52
Screening, Week 52
Number of TEAEs in the patient subpopulations of interest
Time Frame: Up to 52 weeks and 2 weeks of follow-up
TEAEs observed in the specified subpopulations of patients could also be made in order to get a better understanding of whether any of these particular potential risk factors (e.g., old age, cardiovascular disease) define groups with greater or lesser risk.
Up to 52 weeks and 2 weeks of follow-up
Clinical Global Impression of Change
Time Frame: Week 52
Assessment of disease severity will utilize the Clinical Global Impression of Change (CGI-C) scale at end of treatment to evaluate change in disease status since initiation of treatment.
Week 52

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

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.
June 6, 2014

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.
January 31, 2018

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.
January 31, 2018

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).
December 17, 2013

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.
January 9, 2014

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.
January 13, 2014

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.
September 7, 2018

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.
September 6, 2018

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.
November 1, 2015

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-G000-402

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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