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
NCT ID: NCT04252846
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
191 participants
OBSERVATIONAL
2020-07-20
2023-01-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Perampanel
Perampanel oral tablets or oral suspension.
Interventions
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Perampanel
Perampanel oral tablets or oral suspension.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
ALL
No
Sponsors
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Eisai Limited
INDUSTRY
Responsible Party
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Locations
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Sydvestjysk Sygehus Esbjerg
Esbjerg, Region Syddanmark, Denmark
Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, France
Hôpital Roger Salengro
Lille, Nord, France
Centre de consultations Saint-Jean Bâtiment A
Cagnes-sur-Mer, , France
Hopitaux de La Timone
Marseille, , France
Hôpital Robert Debré
Paris, , France
Centre hospitalier de Pau
Pau, , France
Centre Hospitalier Universitaire de Toulouse
Toulouse, , France
CHRU Bretonneau
Tours, , France
Eisai Trial Site #2
Berlin, , Germany
Eisai Trial Site #1
Ulm, , Germany
AORN A Cardarelli
Naples, Campania, Italy
Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia
Udine, Friuli Venezia Giulia, Italy
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, Italy
ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo
Milan, Lombardy, Italy
Ospedale di Merano
Merano, Trentino-Alto Adige, Italy
Ospedale Santa Maria Della Misericordia Di Perugia
Perugia, Umbria, Italy
Ospedale Policlinico San Martino
Genova, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Policlinico Universitario Campus Biomedico Di Roma
Roma, , Italy
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, , Portugal
Centro Hospitalar de São João, E.P.E.
Porto, , Portugal
Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy
Krasnoyarsk, , Russia
City Clinical Hospital #1 n.a. N.I.Pirogov
Moscow, , Russia
Moscow State Medical Stomatological University n.a. A.I. Evdokimov
Moscow, , Russia
Russian National Research Medical University n.a. N.I.Pirogov
Moscow, , Russia
City Neurology Center Sibneuromed LLC
Novosibirsk, , Russia
Regional Treatment and Rehabilitation Center
Tyumen, , Russia
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra, 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
Seville, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Countries
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Other Identifiers
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E2007-M044-512
Identifier Type: -
Identifier Source: org_study_id
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