Clinical trial NCT04252846: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Generalized Epilepsy
Partial Onset Seizures
Generalised Tonic-Clonic Seizures
Keywords: Perampanel
Fycompa
Epilepsy
Seizures
Prospective
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 191
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 300 participants with diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE)

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Retention Rate at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Retention Rate at Month 6
timeFrame: Month 6
measure: Pragmatic Seizure-free Rate at Months 6 and 12
timeFrame: Months 6 and 12
measure: Completer Seizure-free Rate at Months 6 and 12
timeFrame: Months 6 and 12
measure: Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12
timeFrame: Months 6 and 12
measure: 50 Percent (%) Responder Rate at Months 6 and 12
timeFrame: Months 6 and 12
measure: Seizure Worsening Rate at Months 6 and 12
timeFrame: Months 6 and 12
measure: Last Dose of Perampanel at Months 6 and 12
timeFrame: Months 6 and 12
measure: Percentage of Participants by Perampanel Dose Titration Speed
timeFrame: Up to Month 12
measure: Duration of Treatment on Perampanel
timeFrame: Up to Month 12
measure: Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs),Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, and TEAEs by Severity
timeFrame: Up to Month 12
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus Esbjerg
state: South Denmark
city: Rennes
country: France
facility: Hôpital Pontchaillou
state: Ille-et-Vilaine
city: Lille
country: France
facility: Hôpital Roger Salengro
state: Nord
city: Cagnes-sur-Mer
country: France
facility: Centre de consultations Saint-Jean Bâtiment A
city: Marseille
country: France
facility: Hopitaux de La Timone
city: Paris
country: France
facility: Hôpital Robert Debré
city: Pau
country: France
facility: Centre hospitalier de Pau
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
city: Tours
country: France
facility: CHRU Bretonneau
city: Berlin
country: Germany
facility: Eisai Trial Site #2
city: Ulm
country: Germany
facility: Eisai Trial Site #1
city: Naples
country: Italy
facility: AORN A Cardarelli
state: Campania
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
state: Lazio
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
state: Lombardia
city: Merano
country: Italy
facility: Ospedale di Merano
state: Trentino-Alto Adige
city: Perugia
country: Italy
facility: Ospedale Santa Maria Della Misericordia Di Perugia
state: Umbria
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Roma
country: Italy
facility: Policlinico Universitario Campus Biomedico Di Roma
city: Coimbra
country: Portugal
facility: Centro Hospitalar E Universitário de Coimbra EPE
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar de São João, E.P.E.
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
city: Moscow
country: Russian Federation
facility: City Clinical Hospital #1 n.a. N.I.Pirogov
city: Moscow
country: Russian Federation
facility: Moscow State Medical Stomatological University n.a. A.I. Evdokimov
city: Moscow
country: Russian Federation
facility: Russian National Research Medical University n.a. N.I.Pirogov
city: Novosibirsk
country: Russian Federation
facility: City Neurology Center Sibneuromed LLC
city: Tyumen
country: Russian Federation
facility: Regional Treatment and Rehabilitation Center
city: Vigo
country: Spain
facility: CHUVI - H.U. Alvaro Cunqueiro
state: Pontevedra
city: Barcelona
country: Spain
facility: Hospital Universitari Sagrat Cor Quironsalud
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga - Hospital General
city: San Sebastián
country: Spain
facility: Hospital Universitario de Donostia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
Study officials:
References: