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 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.

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

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 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.
Other Name: E2007, Fycompa

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.

Eligibility Gender
All
Eligibility Age
Minimum: 1 Year
Countries
Belgium
Chile
Estonia
Hungary
Latvia
Lithuania
Poland
Spain
Contacts

Eisai Medical Information
1-888-274-2378
esi_medinfo@eisai.com

NCT Number
Keywords
Perampanel
Fycompa
Primary Generalized Tonic-Clonic Seizures
E2007-G000-332
E2007
MeSH Terms
Seizures
Lennox Gastaut Syndrome