NO_LONGER_AVAILABLENot Applicable

An Extended Access Program (EAP) for Perampanel

Belgium, Chile, Czechia

Plain-language 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.

Who can participate

Age range1 Year

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Trial details

NCT IDNCT02307578

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Primary Generalized Tonic-Clonic or Partial Onset Seizures trials