A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

February 8, 2023 updated by: Eisai Limited

A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures [POS] with or without secondary generalization [SG] or for primary generalized tonic-clonic seizures [PGTCS] associated with idiopathic generalized epilepsy [IGE] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their 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.
191

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

  • Denmark
    • South Denmark
      • Esbjerg, South Denmark, Denmark
        • Sydvestjysk Sygehus Esbjerg
  • France
      • Cagnes-sur-Mer, France
        • Centre de consultations Saint-Jean Bâtiment A
      • Marseille, France
        • Hopitaux de La Timone
      • Paris, France
        • Hôpital Robert Debré
      • Pau, France
        • Centre Hospitalier de Pau
      • Toulouse, France
        • Centre Hospitalier Universitaire de Toulouse
      • Tours, France
        • CHRU Bretonneau
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France
        • Hopital Pontchaillou
    • Nord
      • Lille, Nord, France
        • Hopital Roger Salengro
  • Germany
      • Berlin, Germany
        • Eisai Trial Site #2
      • Ulm, Germany
        • Eisai Trial Site #1
  • Italy
      • Genova, Italy
        • Ospedale Policlinico San Martino
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria Federico II
      • Roma, Italy
        • Policlinico Universitario Campus Biomedico Di Roma
    • Campania
      • Naples, Campania, Italy
        • AORN A Cardarelli
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italy
        • Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia
    • Lazio
      • Roma, Lazio, Italy
        • Fondazione PTV Policlinico Tor Vergata
    • Lombardia
      • Milano, Lombardia, Italy
        • ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
    • Trentino-Alto Adige
      • Merano, Trentino-Alto Adige, Italy
        • Ospedale di Merano
    • Umbria
      • Perugia, Umbria, Italy
        • Ospedale Santa Maria della Misericordia di Perugia
  • Portugal
      • Coimbra, Portugal
        • Centro Hospitalar E Universitário de Coimbra EPE
      • Lisboa, Portugal
        • Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
      • Porto, Portugal
        • Centro Hospitalar de São João, E.P.E.
  • Russian Federation
      • Krasnoyarsk, Russian Federation
        • Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
      • Moscow, Russian Federation
        • City Clinical Hospital #1 n.a. N.I.Pirogov
      • Moscow, Russian Federation
        • Moscow State Medical Stomatological University n.a. A.I. Evdokimov
      • Moscow, Russian Federation
        • Russian National Research Medical University n.a. N.I.Pirogov
      • Novosibirsk, Russian Federation
        • City Neurology Center Sibneuromed LLC
      • Tyumen, Russian Federation
        • Regional Treatment and Rehabilitation Center
  • Spain
      • Barcelona, Spain
        • Hospital Universitari Sagrat Cor Quironsalud
      • Granada, Spain
        • Hospital Universitario Virgen De Las Nieves
      • Málaga, Spain
        • Hospital Regional Universitario de Malaga - Hospital General
      • San Sebastián, Spain
        • Hospital Universitario de Donostia
      • Sevilla, Spain
        • Hospital Universitario Virgen Macarena
      • Valladolid, Spain
        • Hospital Clínico Universitario de Valladolid
    • Pontevedra
      • Vigo, Pontevedra, Spain
        • CHUVI - H.U. Alvaro Cunqueiro

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 (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 300 participants with diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE)

Description

Inclusion Criteria:

  1. Diagnosis of epilepsy
  2. History of POS with or without SG or PGTCS associated with IGE
  3. Documented POS with or without SG or PGTCS associated with IGE, within the past 12 months
  4. Previously treated with 1 or 2 AEDs as monotherapy
  5. At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate baseline seizure frequency

Exclusion Criteria:

  1. Episode(s) of status epilepticus within the past 6 months before Screening
  2. Previously treated with 2 or more AEDs in combination (other than during cross-titration between AED monotherapies)

  3. Previous or current use of perampanel

    Note: Retrospective inclusions will be allowed but only if the time between the initiation of perampanel treatment and the inclusion does not exceed 7 calendar days

  4. Hypersensitivity to perampanel or any of the excipients

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 a diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE) will initiate treatment with perampanel as first adjunctive treatment as per the clinical judgment of the treating physician as part of routine clinical care. All participants will be observed prospectively for up to 12 months after initiation of perampanel treatment.
Drug: Perampanel
Perampanel oral tablets or oral suspension.
Other Names:
  • Fycompa

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
Retention Rate at Month 12
Time Frame: Month 12
Retention rate at 12 months is defined as the percentage of participants remaining on perampanel at 12 months.
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
Retention Rate at Month 6
Time Frame: Month 6
Retention rate at 6 months is defined as the percentage of participants remaining on perampanel at 6 months.
Month 6
Pragmatic Seizure-free Rate at Months 6 and 12
Time Frame: Months 6 and 12
Pragmatic seizure-free rate is defined as the percentage of participants (based on all study participants) who are free of all seizures at 6 months (and for the previous 3 months) and at 12 months (and for the previous 6 months).
Months 6 and 12
Completer Seizure-free Rate at Months 6 and 12
Time Frame: Months 6 and 12
Completer seizure-free rate is defined as the percentage of participants (based on a subset of study participants who remain on perampanel treatment at 6 and 12 months) who are free of all seizures at 6 months (and for the previous 3 months) and at 12 months (and for the previous 6 months), respectively.
Months 6 and 12
Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12
Time Frame: Months 6 and 12
Seizure frequency change will be measured at 6 months (averaged over the previous 3 months) and at 12 months (averaged over the previous 6 months).
Months 6 and 12
50 Percent (%) Responder Rate at Months 6 and 12
Time Frame: Months 6 and 12
50% responder rate is defined as the percentage of participants with greater than or equal to (>=) 50% reduction in seizure frequency (averaged over the 3 months before the 6-month visit, and over the 6 months before the12-month visit) relative to baseline.
Months 6 and 12
Seizure Worsening Rate at Months 6 and 12
Time Frame: Months 6 and 12
Seizure worsening rate is defined as the percentage of participants with >=10% increase in seizure frequency (averaged over the 3 months before the 6-month visit, and over the 6 months before the 12-month visit) relative to baseline.
Months 6 and 12
Last Dose of Perampanel at Months 6 and 12
Time Frame: Months 6 and 12
Months 6 and 12
Percentage of Participants by Perampanel Dose Titration Speed
Time Frame: Up to Month 12
Up to Month 12
Duration of Treatment on Perampanel
Time Frame: Up to Month 12
Up to Month 12
Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs),Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, and TEAEs by Severity
Time Frame: Up to Month 12
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 Limited

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.
July 20, 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.
January 12, 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.
January 12, 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).
January 31, 2020

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 31, 2020

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.
February 5, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

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.
February 9, 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.
February 8, 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.
December 1, 2022

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-M044-512

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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