An Extended Access Program (EAP) for Perampanel

NCT02307578 | Unknown

• 1 other identifier: E2007-G000-409
• Study Type: expanded_access
• Target: N/A
• Locations: 9 countries
• Sites: 24

Brief 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.

Conditions

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

Keywords

Perampanel; Fycompa; Primary Generalized Tonic-Clonic Seizures; E2007-G000-332; E2007

Interventions

Perampanel DRUG

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.

Also known as: E2007, Fycompa

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants who provide informed consent where applicable per local requirements.
• 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 \[condom plus spermicide, condom plus diaphragm with spermicide\]).

You may not qualify if:

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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (27)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, Belgium

Location

Centre Neurologique William Lennox

Ottignies, Belgium

Location

Hospital Padre Hurtado

Santiago, Chile

Location

Artroscan

Ostrava-Trebovice, Czechia

Location

Všeobecná fakultní nemocnice, Pragtis s.r.o

Prague, Czechia

Location

Oy Neurodiagnostika Ap

Tallinn, Estonia

Location

Tartu University Hospital

Tartu, Estonia

Location

Dél-Pesti Centrumkórház Országos Hematológiai és Infektológiai Intézet

Budapest, Hungary

Location

Magyarorszagi Reformatus Egyhaz (MRE) Bethesda Gyermekkorhaza

Budapest, Hungary

Location

Országos Idegsebészeti Tudományos Intézet

Budapest, Hungary

Location

Rajna és Fiai Kereskedelmi és Szolgáltató Kft.

Budapest, Hungary

Location

Servus Salvus Egeszsegugyi Szolgaltato Kft.

Budapest, Hungary

Location

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

Miskolc, Hungary

Location

Pécsi Tudományegyetem

Pécs, Hungary

Location

Childrens University Hospital

Riga, Latvia

Location

Riga 1st Hospital

Riga, Latvia

Location

Klaipeda University Hospital

Klaipėda, Lithuania

Location

Uniwersyteckie Centrum Kliniczne - PPDS

Gdansk, Poland

Location

Nzoz Novo-Med

Katowice, Poland

Location

NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki

Kielce, Poland

Location

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

Poznan, Poland

Location

Instytut Psychiatrii Neurologii

Warsaw, Poland

Location

Clinical Centre of Serbia

Belgrade, Serbia

Location

Hospital Sant Joan de Deu

Esplugues de Llobregat, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Universitario Virgen del Rocio -

Seville, Spain

Location

MeSH Terms

Conditions

Lennox Gastaut Syndrome

Interventions

perampanel

Condition Hierarchy (Ancestors)

Epileptic Syndromes; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 4, 2014
• Last Updated: September 15, 2025

Record last verified: 2025-03

Locations

PL (5); LI (1); LA (2); CZ (2); BE (3); HU (7); CL (1); ES (2); SE (1)