Access Program Information
The Extended Access Program (EAP) is a managed access programme for Perampanel. The main
objective of this EAP is to ensure that patients participating in studies E2007-A001-207,
E2007-G000-307, or E2007-G000-235 continue to have access to perampanel until such time
perampanel tablets become commercially available for the treatment of Partial Onset Seizures
(POS) in the country in which they reside. This EAP will consist of 2 phases:
– Screening: The patient will start the program once the Screening assessments are
completed and the patient is qualified for participation.
– Treatment: Additional assessments, physical examinations, and dosage changes will be
clinically determined by the treating physician.
Patients will enter this program on the same dose of perampanel that they were receiving at
the end of their participation in previous study. Doses of perampanel and of concomitant
anti-epileptic drugs (AEDs) can be adjusted (i.e., added,removed, or changed in dose) based
on clinical judgment.
Treatment will be prescribed as long as clinically appropriate according to the judgement of
the treating physician and the approved Summary of Product Characteristics (SmPC).
The program will complete in a staggered fashion, country by country, as and when perampanel
becomes commercially available for the treatment of POS in each country.