A Study to Evaluate the Effectiveness of Perampanel as Only Add-on Treatment in Participants With Primary or Secondarily Generalized Tonic-clonic Seizures

August 2, 2023 updated by: Eisai GmbH

PERPRISE: A Prospective Non-interventional Study Evaluating the Effectiveness of Perampanel (Fycompa®) as Only Add-on Treatment in Patients With Primary or Secondarily Generalized Tonic-clonic Seizures

The primary purpose of this study is to investigate the effectiveness reflected by the retention rate of perampanel as the only add-on treatment in adult participants with primary generalized tonic-clonic (PGTC) or secondarily generalized tonic-clonic (SGTC) seizures based on focal or idiopathic generalized epilepsy in a non-interventional (observational) setting.

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.
187

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

  • Germany
      • Aalen, Germany
        • Eisai Trial Site #51
      • Berlin, Germany
        • Eisai Trial Site #12
      • Berlin, Germany
        • Eisai Trial Site #43
      • Bernau, Germany
        • Eisai Trial Site #15
      • Bielefeld, Germany
        • Eisai Trial Site #8
      • Bochum, Germany
        • Eisai Trial Site #53
      • Bonn, Germany
        • Eisai Trial Site #38
      • Bonn, Germany
        • Eisai Trial Site #9
      • Damp, Germany
        • Eisai Trial Site #25
      • Dortmund, Germany
        • Eisai Trial Site #48
      • Dresden, Germany
        • Eisai Trial Site #27
      • Dresden, Germany
        • Eisai Trial Site #50
      • Erlangen, Germany
        • Eisai Trial Site #7
      • Friedrichshafen, Germany
        • Eisai Trial Site #44
      • Greifswald, Germany
        • Eisai Trial Site #4
      • Hamburg, Germany
        • Eisai Trial Site #21
      • Hamburg, Germany
        • Eisai Trial Site #47
      • Jena, Germany
        • Eisai Trial Site #14
      • Kiel, Germany
        • Eisai Trial Site #18
      • Kiel, Germany
        • Eisai Trial Site #54
      • Kork, Germany
        • Eisai Trial Site #1
      • Leipzig, Germany
        • Eisai Trial Site #24
      • Lübeck, Germany
        • Eisai Trial Site #28
      • Magdeburg, Germany
        • Eisai Trial Site #26
      • Mainz, Germany
        • Eisai Trial Site #13
      • Mittweida, Germany
        • Eisai Trial Site #36
      • Nierstein, Germany
        • Eisai Trial Site #42
      • Radeberg, Germany
        • Eisai Trial Site #2
      • Ravensburg, Germany
        • Eisai Trial Site #16
      • Regensburg, Germany
        • Eisai Trial Site #23
      • Remscheid, Germany
        • Eisai Trial Site #46
      • Tübingen, Germany
        • Eisai Trial Site #3
      • Ulm, Germany
        • Eisai Trial Site #37
      • Weil der Stadt, Germany
        • Eisai Trial Site #40

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants with PGTC or SGTC seizures.

Description

Inclusion Criteria:

  1. Confirmed diagnosis of epilepsy with PGTC or SGTC seizures based on focal or idiopathic generalized epilepsy
  2. Active epilepsy with GTC seizures, demonstrated by the occurrence of at least 1 GTC seizure within 3 months before inclusion
  3. The decision to prescribe perampanel was made by the physician before and irrespective of his/her decision to include the participant in the study
  4. Receiving treatment with perampanel in line with the current Fycompa (perampanel) SmPC
  5. Perampanel must either be newly administered as the only add-on treatment to a current antiepileptic drug (AED) monotherapy or must be planned to substitute one of two AEDs of a current dual therapy planned to be stopped within 2 months after initiation of treatment with perampanel. It will be specified which AED is planned to be substituted by perampanel upon inclusion. It is assumed that participants start treatment with perampanel closely after the baseline visit. Retrospective inclusions will be allowed, but only if the time between the initiation of perampanel treatment and inclusion does not exceed 7 calendar days. In this case, the baseline visit documentation should reflect the situation (including seizure situation 3 months before baseline and baseline medication) to the date perampanel treatment was initiated

Exclusion Criteria:

  1. Participants with known psychogenic non-epileptic seizures
  2. The participant had already received perampanel in the past
  3. Simultaneous participation in an interventional clinical study and/or taking an investigational drug

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.
Perampanel
Participants with PGTC or SGTC seizures may receive perampanel tablets or oral suspension as only add-on therapy based on physicians decision in accordance with summary of product characteristics (SmPC) and will be observed at baseline, 6 months (intermediate visit), and 12 months (final visit).
Drug: Perampanel
Perampanel tablets.
Other Names:
  • Fycompa
  • E2007
Drug: Perampanel
Perampanel oral suspension.
Other Names:
  • Fycompa
  • E2007

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 Perampanel at Month 12 (Retention Rate)
Time Frame: Month 12
The retention rate is defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.
Month 12

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 Remaining on Perampanel at Month 6 (Retention Rate)
Time Frame: Month 6
The retention rate is defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment.
Month 6
Percentage of Participants Who Achieved Seizure Freedom for All Generalized Tonic-clonic (GTC) Seizures at Month 12
Time Frame: Month 12
Month 12
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Treatment-emergent Serious Adverse Events (SAE), and Adverse Events (AEs) by Severity
Time Frame: Up to Month 12
AEs will be graded on a 3-point scale that is mild (discomfort noticed, but no disruption of normal daily activity), moderate (discomfort sufficient to reduce or affect normal daily activity), and severe (incapacitating, with inability to work or to perform normal daily activity).
Up to Month 12

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 GmbH

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.
January 21, 2020

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 31, 2023

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 31, 2023

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 16, 2019

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.
December 16, 2019

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.
December 17, 2019

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.
August 3, 2023

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.
August 2, 2023

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.
August 1, 2023

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-M049-509

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

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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