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An Extended Access Program (EAP) for Perampanel

NCT ID: NCT02307578

Last Updated: 2025-09-15

Study Results

Results pending

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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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Generalized Tonic-Clonic or Partial Onset Seizures Lennox Gastaut Syndrome

Interventions

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Perampanel

Perampanel will be available in 2-milligrams (mg), 4-mg and 8-mg tablets and as 0.5 milligram per milliliter (mg/mL) oral suspension. Participants will start this EAP with the dose that they were receiving at the end of their participation in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401. Doses of perampanel can be adjusted based on clinical judgment.

Intervention Type DRUG

Other Intervention Names

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E2007, Fycompa

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, , Belgium

Site Status

Centre Neurologique William Lennox

Ottignies, , Belgium

Site Status

Hospital Padre Hurtado

Santiago, , Chile

Site Status

Artroscan

Ostrava-Trebovice, , Czechia

Site Status

Všeobecná fakultní nemocnice, Pragtis s.r.o

Prague, , Czechia

Site Status

Oy Neurodiagnostika Ap

Tallinn, , Estonia

Site Status

Tartu University Hospital

Tartu, , Estonia

Site Status

Dél-Pesti Centrumkórház Országos Hematológiai és Infektológiai Intézet

Budapest, , Hungary

Site Status

Magyarorszagi Reformatus Egyhaz (MRE) Bethesda Gyermekkorhaza

Budapest, , Hungary

Site Status

Országos Idegsebészeti Tudományos Intézet

Budapest, , Hungary

Site Status

Rajna és Fiai Kereskedelmi és Szolgáltató Kft.

Budapest, , Hungary

Site Status

Servus Salvus Egeszsegugyi Szolgaltato Kft.

Budapest, , Hungary

Site Status

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

Miskolc, , Hungary

Site Status

Pécsi Tudományegyetem

Pécs, , Hungary

Site Status

Childrens University Hospital

Riga, , Latvia

Site Status

Riga 1st Hospital

Riga, , Latvia

Site Status

Klaipeda University Hospital

Klaipėda, , Lithuania

Site Status

Uniwersyteckie Centrum Kliniczne - PPDS

Gdansk, , Poland

Site Status

Nzoz Novo-Med

Katowice, , Poland

Site Status

NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki

Kielce, , Poland

Site Status

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

Poznan, , Poland

Site Status

Instytut Psychiatrii Neurologii

Warsaw, , Poland

Site Status

Clinical Centre of Serbia

Belgrade, , Serbia

Site Status

Hospital Sant Joan de Deu

Esplugues de Llobregat, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario Virgen del Rocio -

Seville, , Spain

Site Status

Countries

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Belgium Chile Czechia Estonia Hungary Latvia Lithuania Poland Serbia Spain

Other Identifiers

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E2007-G000-409

Identifier Type: -

Identifier Source: org_study_id

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