Clinical trial NCT04202159: A Study to Evaluate the Effectiveness of Perampanel as Only Add-on Treatment in Participants With Primary or Secondarily Generalized Tonic-clonic Seizures
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizures
Keywords: E2007
Perampanel
Fycompa
Primary generalized tonic-clonic seizures
Secondarily generalized tonic-clonic seizures
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-17
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with PGTC or SGTC seizures.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Remaining on Perampanel at Month 12 (Retention Rate)
timeFrame: Month 12
Secondary outcomes:
measure: Percentage of Participants Remaining on Perampanel at Month 6 (Retention Rate)
timeFrame: Month 6
measure: Percentage of Participants Who Achieved Seizure Freedom for All Generalized Tonic-clonic (GTC) Seizures at Month 12
timeFrame: Month 12
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Treatment-emergent Serious Adverse Events (SAE), and Adverse Events (AEs) by Severity
timeFrame: Up to Month 12
Other outcomes:
Locations:
city: Aalen
country: Germany
facility: Eisai Trial Site #51
city: Berlin
country: Germany
facility: Eisai Trial Site #12
city: Berlin
country: Germany
facility: Eisai Trial Site #43
city: Bernau
country: Germany
facility: Eisai Trial Site #15
city: Bielefeld
country: Germany
facility: Eisai Trial Site #8
city: Bochum
country: Germany
facility: Eisai Trial Site #53
city: Bonn
country: Germany
facility: Eisai Trial Site #38
city: Bonn
country: Germany
facility: Eisai Trial Site #9
city: Damp
country: Germany
facility: Eisai Trial Site #25
city: Dortmund
country: Germany
facility: Eisai Trial Site #48
city: Dresden
country: Germany
facility: Eisai Trial Site #27
city: Dresden
country: Germany
facility: Eisai Trial Site #50
city: Erlangen
country: Germany
facility: Eisai Trial Site #7
city: Friedrichshafen
country: Germany
facility: Eisai Trial Site #44
city: Greifswald
country: Germany
facility: Eisai Trial Site #4
city: Hamburg
country: Germany
facility: Eisai Trial Site #21
city: Hamburg
country: Germany
facility: Eisai Trial Site #47
city: Jena
country: Germany
facility: Eisai Trial Site #14
city: Kiel
country: Germany
facility: Eisai Trial Site #18
city: Kiel
country: Germany
facility: Eisai Trial Site #54
city: Kork
country: Germany
facility: Eisai Trial Site #1
city: Leipzig
country: Germany
facility: Eisai Trial Site #24
city: Lübeck
country: Germany
facility: Eisai Trial Site #28
city: Magdeburg
country: Germany
facility: Eisai Trial Site #26
city: Mainz
country: Germany
facility: Eisai Trial Site #13
city: Mittweida
country: Germany
facility: Eisai Trial Site #36
city: Nierstein
country: Germany
facility: Eisai Trial Site #42
city: Radeberg
country: Germany
facility: Eisai Trial Site #2
city: Ravensburg
country: Germany
facility: Eisai Trial Site #16
city: Regensburg
country: Germany
facility: Eisai Trial Site #23
city: Remscheid
country: Germany
facility: Eisai Trial Site #46
city: Tübingen
country: Germany
facility: Eisai Trial Site #3
city: Ulm
country: Germany
facility: Eisai Trial Site #37
city: Weil der Stadt
country: Germany
facility: Eisai Trial Site #40
Study officials:
References: