Lennox Gastaut Syndrome, Primary Generalized Tonic-Clonic or Partial Onset Seizures
Conditions
Keywords
Perampanel, Fycompa, Primary Generalized Tonic-Clonic Seizures, E2007-G000-332, E2007
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.
Interventions
DRUGPerampanel
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.
Sponsors
Eisai Inc.
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
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.
Countries
Belgium, Chile, Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, Serbia, Spain
Outcome results
None listed