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
- Conditions
- Generalised Tonic-Clonic SeizuresIdiopathic Generalized EpilepsyPartial Onset Seizures
- Interventions
- Registration Number
- NCT04252846
- Lead Sponsor
- Eisai Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
- 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
-
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Perampanel 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (36)
Fondazione PTV Policlinico Tor Vergata
🇮🇹Roma, Lazio, Italy
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
CHUVI - H.U. Alvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Ospedale Santa Maria Della Misericordia Di Perugia
🇮🇹Perugia, Umbria, Italy
Hôpital Pontchaillou
🇫🇷Rennes, Ille-et-Vilaine, France
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
Centre de consultations Saint-Jean Bâtiment A
🇫🇷Cagnes-sur-Mer, France
Sydvestjysk Sygehus Esbjerg
🇩🇰Esbjerg, South Denmark, Denmark
Centre hospitalier de Pau
🇫🇷Pau, France
Hôpital Roger Salengro
🇫🇷Lille, Nord, France
City Neurology Center Sibneuromed LLC
🇷🇺Novosibirsk, Russian Federation
Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia
🇮🇹Udine, Friuli-Venezia Giulia, Italy
Hopitaux de La Timone
🇫🇷Marseille, France
Policlinico Universitario Campus Biomedico Di Roma
🇮🇹Roma, Italy
Centro Hospitalar E Universitário de Coimbra EPE
🇵🇹Coimbra, Portugal
Centro Hospitalar de São João, E.P.E.
🇵🇹Porto, Portugal
Hôpital Robert Debré
🇫🇷Paris, France
Centre Hospitalier Universitaire de Toulouse
🇫🇷Toulouse, France
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Regional Treatment and Rehabilitation Center
🇷🇺Tyumen, Russian Federation
Russian National Research Medical University n.a. N.I.Pirogov
🇷🇺Moscow, Russian Federation
Eisai Trial Site #2
🇩🇪Berlin, Germany
Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Eisai Trial Site #1
🇩🇪Ulm, Germany
CHRU Bretonneau
🇫🇷Tours, France
AORN A Cardarelli
🇮🇹Naples, Campania, Italy
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
🇮🇹Milano, Lombardia, Italy
Ospedale di Merano
🇮🇹Merano, Trentino-Alto Adige, Italy
Moscow State Medical Stomatological University n.a. A.I. Evdokimov
🇷🇺Moscow, Russian Federation
Hospital Universitario Virgen de Las Nieves
🇪🇸Granada, Spain
Hospital Regional Universitario de Malaga - Hospital General
🇪🇸Málaga, Spain
Hospital Universitari Sagrat Cor Quironsalud
🇪🇸Barcelona, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Universitario de Donostia
🇪🇸San Sebastián, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain