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

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: Completed
• Conditions: Seizures
• Intervention / Treatment: Drug: Perampanel; Drug: Perampanel

• Study Type: Observational
• Enrollment (Actual): 187

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 16 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

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 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

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Remaining on Perampanel at Month 12 (Retention Rate)	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

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Remaining on Perampanel at Month 6 (Retention Rate)	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		Month 12
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Treatment-emergent Serious Adverse Events (SAE), and Adverse Events (AEs) by Severity	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

• Sponsor: Eisai GmbH

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Perampanel; Fycompa; E2007; Primary generalized tonic-clonic seizures; Secondarily generalized tonic-clonic seizures
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID 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