An Extended Access Program (EAP) for Perampanel

September 8, 2025 updated by: Eisai Inc.
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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Cliniques universitaires Saint-Luc
      • Brussels, Belgium
        • Hôpital Universitaire Des Enfants Reine Fabiola
      • Ottignies, Belgium
        • Centre Neurologique William Lennox
  • Chile
      • Santiago, Chile
        • Hospital Padre Hurtado
  • Czechia
      • Ostrava-Trebovice, Czechia
        • Artroscan
      • Prague, Czechia
        • Všeobecná fakultní nemocnice, Pragtis s.r.o
  • Estonia
      • Tallinn, Estonia
        • Oy Neurodiagnostika Ap
      • Tartu, Estonia
        • Tartu University Hospital
  • Hungary
      • Budapest, Hungary
        • Dél-Pesti Centrumkórház Orszagos Hematologiai es Infektologiai Intezet
      • Budapest, Hungary
        • Magyarorszagi Reformatus Egyhaz (MRE) Bethesda Gyermekkorhaza
      • Budapest, Hungary
        • Országos Idegsebészeti Tudományos Intézet
      • Budapest, Hungary
        • Rajna és Fiai Kereskedelmi és Szolgáltató Kft.
      • Budapest, Hungary
        • Servus Salvus Egészségügyi Szolgáltató Kft.
      • Miskolc, Hungary
        • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
      • Pécs, Hungary
        • Pécsi Tudományegyetem
  • Latvia
      • Riga, Latvia
        • Riga 1st Hospital
      • Riga, Latvia
        • Childrens University Hospital
  • Lithuania
      • Klaipėda, Lithuania
        • Klaipeda university hospital
  • Poland
      • Gdansk, Poland
        • Uniwersyteckie Centrum Kliniczne - PPDS
      • Katowice, Poland
        • Nzoz Novo-Med
      • Kielce, Poland
        • NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
      • Poznan, Poland
        • Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
      • Warsaw, Poland
        • Instytut Psychiatrii Neurologii
  • Serbia
      • Belgrade, Serbia
        • Clinical Centre of Serbia
  • Spain
      • Esplugues de Llobregat, Spain
        • Hospital Sant Joan de Déu
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Seville, Spain
        • Hospital Universitario Virgen del Rocio -

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion criteria:

  1. Participants who have completed their participation in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338, or who are being rolled over from EAP E2007-G000-401 and, who in the opinion of the treating physician, continue to demonstrate 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 the program and for a period of at least 1 month following last dose of perampanel to be abstinent or to commit to the consistent and correct use of a medically acceptable method of birth control (example, a double-barrier method [condom plus spermicide, condom plus diaphragm with spermicide]).

Exclusion criteria:

  1. Participants who reside in countries where the appropriate formulation of perampanel is commercially available.
  2. Female participants who are nursing, pregnant, or planning to become pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimated)

December 4, 2014

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2007-G000-409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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