Status:
NO_LONGER_AVAILABLE
An Extended Access Program (EAP) for Perampanel
Lead Sponsor:
Eisai Inc.
Conditions:
Primary Generalized Tonic-Clonic or Partial Onset Seizures
Lennox Gastaut Syndrome
Eligibility:
All Genders
1+ years
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02307578
Last Update
September 15 2025
Active Locations (27)
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1
Cliniques Universitaires Saint-Luc
Brussels, Belgium
2
Hôpital Universitaire des Enfants Reine Fabiola
Brussels, Belgium
3
Centre Neurologique William Lennox
Ottignies, Belgium
4
Hospital Padre Hurtado
Santiago, Chile