Eisai Inc.

An Extended Access Program (EAP) for Perampanel

Official Title: 
An Extended Access Program (EAP) for Perampanel
Brief Summary: 
The main objective of this EAP is to ensure that participants participating in Study E2007-G000-332, Study 311 or EAP 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.
Primary Generalized Tonic-Clonic or Partial Onset Seizures

Drug: 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 332, Study 311, or EAP 401. Doses of perampanel can be adjusted based on clinical judgment.
Other Name: E2007, Fycompa

Eligibility Criteria: 

Inclusion criteria:

1. Participants who have completed their participation in Study 332 or Study 311, or who are being rolled over from EAP 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.

Eligibility Gender: 
Eligibility Age: 
Minimum: 4 Years
Belgium, Estonia, Hungary, Latvia, Lithuania, Poland, Spain

Eisai Medical Information

Eisai Inc.
EA Number: 
Perampanel, Fycompa, Primary Generalized Tonic-Clonic Seizures, E2007-G000-332, E2007
MeSH Terms: 
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