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

Sponsor

Eisai Limited (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04252846

Collaborator

(none)

300

Enrollment

Locations

29.4

Anticipated Duration (Months)

8.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Generalized Epilepsy Partial Onset Seizures Generalised Tonic-Clonic Seizures	Drug: Perampanel

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jul 20, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Retention Rate at Month 12 [Month 12]
Retention rate at 12 months is defined as the percentage of participants remaining on perampanel at 12 months.

Secondary Outcome Measures

Retention Rate at Month 6 [Month 6]
Retention rate at 6 months is defined as the percentage of participants remaining on perampanel at 6 months.
Pragmatic Seizure-free Rate at Months 6 and 12 [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).
Completer Seizure-free Rate at Months 6 and 12 [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.
Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12 [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).
50 Percent (%) Responder Rate at Months 6 and 12 [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.
Seizure Worsening Rate at Months 6 and 12 [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.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of epilepsy
History of POS with or without SG or PGTCS associated with IGE
Documented POS with or without SG or PGTCS associated with IGE, within the past 12 months
Previously treated with 1 or 2 AEDs as monotherapy
At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate baseline seizure frequency

Exclusion Criteria:

Episode(s) of status epilepticus within the past 6 months before Screening
Previously treated with 2 or more AEDs in combination (other than during cross-titration between AED monotherapies)
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

Hypersensitivity to perampanel or any of the excipients

Contacts and Locations

Locations

	Site	City	State	Country
1	Sydvestjysk Sygehus Esbjerg	Esbjerg	South Denmark	Denmark
2	Hôpital Pontchaillou	Rennes	Ille-et-Vilaine	France
3	Hôpital Roger Salengro	Lille	Nord	France
4	Centre de consultations Saint-Jean Bâtiment A	Cagnes-sur-Mer		France
5	Hopitaux de La Timone	Marseille		France
6	Hôpital Robert Debré	Paris		France
7	Centre hospitalier de Pau	Pau		France
8	Centre Hospitalier Universitaire de Toulouse	Toulouse		France
9	Hôpital Trousseau	Tours		France
10	Eisai Trial Site #2	Berlin		Germany
11	Eisai Trial Site #1	Ulm		Germany
12	AORN A Cardarelli	Naples	Campania	Italy
13	Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia	Udine	Friuli-Venezia Giulia	Italy
14	Fondazione PTV Policlinico Tor Vergata	Roma	Lazio	Italy
15	ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo	Milano	Lombardia	Italy
16	Ospedale di Merano	Merano	Trentino-Alto Adige	Italy
17	Ospedale Santa Maria Della Misericordia Di Perugia	Perugia	Umbria	Italy
18	Ospedale Policlinico San Martino	Genova		Italy
19	Azienda Ospedaliera Universitaria Federico II	Napoli		Italy
20	Policlinico Universitario Campus Biomedico Di Roma	Roma		Italy
21	Centro Hospitalar E Universitário de Coimbra EPE	Coimbra		Portugal
22	Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria	Lisboa		Portugal
23	Centro Hospitalar de São João, E.P.E.	Porto		Portugal
24	Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy	Krasnoyarsk		Russian Federation
25	City Clinical Hospital #1 n.a. N.I.Pirogov	Moscow		Russian Federation
26	Moscow State Medical Stomatological University n.a. A.I. Evdokimov	Moscow		Russian Federation
27	Russian National Research Medical University n.a. N.I.Pirogov	Moscow		Russian Federation
28	City Neurology Center Sibneuromed LLC	Novosibirsk		Russian Federation
29	Regional Treatment and Rehabilitation Center	Tyumen		Russian Federation
30	CHUVI - H.U. Alvaro Cunqueiro	Vigo	Pontevedra	Spain
31	Hospital Universitari Sagrat Cor Quironsalud	Barcelona		Spain
32	Hospital Universitario Virgen de Las Nieves	Granada		Spain
33	Hospital Regional Universitario de Malaga - Hospital General	Málaga		Spain
34	Hospital Universitario de Donostia	San Sebastián		Spain
35	Hospital Universitario Virgen Macarena	Sevilla		Spain
36	Hospital Clinico Universitario de Valladolid	Valladolid		Spain