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

Partial Onset Seizures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04252846
• Other study ID #: E2007-M044-512
• Status: Completed
• Start date: July 20, 2020
• Est. completion date: January 12, 2023

Study information

• Verified date: December 2022
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: January 12, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Generalized
• Generalised Tonic-Clonic Seizures
• Idiopathic Generalized Epilepsy
• Partial Onset Seizures
• Seizures

Intervention

Drug:
• Perampanel
Perampanel oral tablets or oral suspension.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Limited

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Italy,  Portugal,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Last Dose of Perampanel at Months 6 and 12		Months 6 and 12
Secondary	Percentage of Participants by Perampanel Dose Titration Speed		Up to Month 12
Secondary	Duration of Treatment on Perampanel		Up to Month 12
Secondary	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