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

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: Completed
• Conditions: Idiopathic Generalized Epilepsy; Partial Onset Seizures; Generalised Tonic-Clonic Seizures
• Intervention / Treatment: Drug: Perampanel

• Study Type: Observational
• Enrollment (Actual): 191

Contacts and Locations

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
    • Hopital Robert Debre
  • 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
      • Hôpital 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 Universitario 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Retention Rate at 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

Outcome Measure	Measure Description	Time Frame
Retention Rate at 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	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	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	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	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	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		Months 6 and 12
Percentage of Participants by Perampanel Dose Titration Speed		Up to Month 12
Duration of Treatment on Perampanel		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		Up to Month 12

Collaborators and Investigators

• Sponsor: Eisai Limited

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2020
• Primary Completion (ACTUAL): January 12, 2023
• Study Completion (ACTUAL): January 12, 2023

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Epilepsy; Seizures; Prospective; Perampanel; Fycompa
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Epilepsy, Generalized
• Other Study ID 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