Clinical trial NCT02307578: An Extended Access Program (EAP) for Perampanel
Official title: An Extended Access Program (EAP) for Perampanel
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Primary Generalized Tonic-Clonic or Partial Onset Seizures
Lennox Gastaut Syndrome
Keywords: Perampanel
Fycompa
Primary Generalized Tonic-Clonic Seizures
E2007-G000-332
E2007
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-04
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT

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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Brussels
country: Belgium
facility: Hôpital Universitaire des Enfants Reine Fabiola
city: Ottignies
country: Belgium
facility: Centre Neurologique William Lennox
city: Santiago
country: Chile
facility: Hospital Padre Hurtado
city: Ostrava-Trebovice
country: Czechia
facility: Artroscan
city: Prague
country: Czechia
facility: Všeobecná fakultní nemocnice, Pragtis s.r.o
city: Tallinn
country: Estonia
facility: Oy Neurodiagnostika Ap
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Budapest
country: Hungary
facility: Dél-Pesti Centrumkórház Országos Hematológiai és Infektológiai Intézet
city: Budapest
country: Hungary
facility: Magyarorszagi Reformatus Egyhaz (MRE) Bethesda Gyermekkorhaza
city: Budapest
country: Hungary
facility: Országos Idegsebészeti Tudományos Intézet
city: Budapest
country: Hungary
facility: Rajna és Fiai Kereskedelmi és Szolgáltató Kft.
city: Budapest
country: Hungary
facility: Servus Salvus Egeszsegugyi Szolgaltato Kft.
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem
city: Riga
country: Latvia
facility: Childrens University Hospital
city: Riga
country: Latvia
facility: Riga 1st Hospital
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne - PPDS
city: Katowice
country: Poland
facility: Nzoz Novo-Med
city: Kielce
country: Poland
facility: NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
city: Poznan
country: Poland
facility: Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
city: Warsaw
country: Poland
facility: Instytut Psychiatrii Neurologii
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio -
Study officials:
References: