An Extended Access Program (EAP) for Perampanel

Sponsor

Eisai Inc. (Industry)

Overall Status

Available

CT.gov ID

NCT02307578

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Generalized Tonic-Clonic or Partial Onset Seizures Lennox Gastaut Syndrome	Drug: Perampanel

Study Design

Study Type:

Expanded Access

Official Title:

An Extended Access Program (EAP) for Perampanel

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year and Older

Sexes Eligible for Study:

All

Inclusion criteria:

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]).

Exclusion criteria:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cliniques Universitaires Saint-Luc	Brussels	Belgium
2	Hôpital Universitaire des Enfants Reine Fabiola	Brussels	Belgium
3	Centre Neurologique William Lennox	Ottignies	Belgium
4	Hospital Padre Hurtado	Santiago	Chile
5	Oy Neurodiagnostika Ap	Tallinn	Estonia
6	Tartu University Hospital	Tartu	Estonia
7	Dél-Pesti Centrumkórház Országos Hematológiai és Infektológiai Intézet	Budapest	Hungary
8	Magyarorszagi Reformatus Egyhaz (MRE) Bethesda Gyermekkorhaza	Budapest	Hungary
9	Országos Idegsebészeti Tudományos Intézet	Budapest	Hungary
10	Rajna és Fiai Kereskedelmi és Szolgáltató Kft.	Budapest	Hungary
11	Servus Salvus Egeszsegugyi Szolgaltato Kft.	Budapest	Hungary
12	Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház	Miskolc	Hungary
13	Pécsi Tudományegyetem	Pécs	Hungary
14	Pharmacy, Riga 1st Hospital	Riga	Latvia	LV-1001
15	Childrens University Hospital	Riga	Latvia
16	Klaipeda University Hospital	Klaipeda	Lithuania
17	Uniwersyteckie Centrum Kliniczne - PPDS	Gdansk	Poland
18	NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki	Kielce	Poland
19	Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu	Poznan	Poland
20	Hospital Sant Joan de Deu	Esplugues de Llobregat	Spain
21	Hospital Clinico San Carlos	Madrid	Spain
22	Hospital Universitario Virgen del Rocio -	Sevilla	Spain