An Extended Access Program (EAP) for Perampanel

Last updated: March 9, 2025
Sponsor: Eisai Inc.
Overall Status: Planned

Phase

N/A

Condition

N/A

Treatment

Perampanel

Clinical Study ID

NCT02307578
E2007-G000-409
  • Ages > 1
  • All Genders

Study Summary

The main objective of this EAP is to ensure that participants participating in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401 continue to have access to perampanel until such time that the appropriate formulation of perampanel becomes commercially available in the country in which they reside or until no participants remain in the EAP.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Participants who have completed their participation in Study E2007-G000-332, StudyE2007-G000-311, E2007-G000-238, E2007-G000-338, or who are being rolled over fromEAP E2007-G000-401 and, who in the opinion of the treating physician, continue todemonstrate a positive benefit-to-risk ratio from treatment with perampanel.

  2. Participants who provide informed consent where applicable per local requirements.

  3. Female participants of childbearing potential must agree for the duration of theprogram and for a period of at least 1 month following last dose of perampanel to beabstinent or to commit to the consistent and correct use of a medically acceptablemethod of birth control (example, a double-barrier method [condom plus spermicide,condom plus diaphragm with spermicide]).

Exclusion

Exclusion criteria:

  1. Participants who reside in countries where the appropriate formulation of perampanelis commercially available.

  2. Female participants who are nursing, pregnant, or planning to become pregnant.

Study Design

Treatment Group(s): 1
Primary Treatment: Perampanel
Phase:
Study Start date:
Estimated Completion Date:

Connect with a study center

  • Cliniques Universitaires Saint-Luc

    Brussels,
    Belgium

    Planned

  • Hôpital Universitaire des Enfants Reine Fabiola

    Brussels,
    Belgium

    Planned

  • Centre Neurologique William Lennox

    Ottignies,
    Belgium

    Planned

  • Hospital Padre Hurtado

    Santiago,
    Chile

    Planned

  • Artroscan

    Ostrava-Trebovice,
    Czechia

    Planned

  • Všeobecná fakultní nemocnice, Pragtis s.r.o

    Prague,
    Czechia

    Planned

  • Oy Neurodiagnostika Ap

    Tallinn,
    Estonia

    Planned

  • Tartu University Hospital

    Tartu,
    Estonia

    Planned

  • Dél-Pesti Centrumkórház Országos Hematológiai és Infektológiai Intézet

    Budapest,
    Hungary

    Planned

  • Magyarorszagi Reformatus Egyhaz (MRE) Bethesda Gyermekkorhaza

    Budapest,
    Hungary

    Planned

  • Országos Idegsebészeti Tudományos Intézet

    Budapest,
    Hungary

    Planned

  • Rajna és Fiai Kereskedelmi és Szolgáltató Kft.

    Budapest,
    Hungary

    Planned

  • Servus Salvus Egeszsegugyi Szolgaltato Kft.

    Budapest,
    Hungary

    Planned

  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház

    Miskolc,
    Hungary

    Planned

  • Pécsi Tudományegyetem

    Pécs,
    Hungary

    Planned

  • Childrens University Hospital

    Riga,
    Latvia

    Planned

  • Pharmacy, Riga 1st Hospital

    Riga, LV-1001
    Latvia

    Planned

  • Riga 1st Hospital

    Riga,
    Latvia

    Planned

  • Klaipeda University Hospital

    Klaipeda,
    Lithuania

    Planned

  • Uniwersyteckie Centrum Kliniczne - PPDS

    Gdansk,
    Poland

    Planned

  • Nzoz Novo-Med

    Katowice,
    Poland

    Planned

  • NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki

    Kielce,
    Poland

    Planned

  • Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

    Poznan,
    Poland

    Planned

  • Instytut Psychiatrii Neurologii

    Warsaw,
    Poland

    Planned

  • Clinical Centre of Serbia

    Belgrade,
    Serbia

    Planned

  • Hospital Sant Joan de Deu

    Esplugues de Llobregat,
    Spain

    Planned

  • Hospital Clinico San Carlos

    Madrid,
    Spain

    Planned

  • Hospital Universitario Virgen del Rocio -

    Sevilla,
    Spain

    Planned

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