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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04252846
Other study ID # E2007-M044-512
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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