An Extended Access Program for Perampanel

Status:

NO_LONGER_AVAILABLE

An Extended Access Program for Perampanel

Lead Sponsor:

Eisai Inc.

Conditions:

Partial Onset Seizures

Eligibility:

All Genders

12-70 years

Brief Summary

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 E2...

Eligibility Criteria

Inclusion

Patients who are participating in either Study 207, Study 307, or Study 235 and who in the opinion of the treating physician, continue to benefit from treatment with perampanel (revised per Amendment 01)
Patients who provide informed consent where applicable per local requirements.
Female patients 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 (e.g., a double-barrier method \[condom plus spermicide, condom plus diaphragm with spermicide\])

Exclusion

Patients residing in countries where perampanel is commercially available for the treatment of POS
Female patients who are lactating, pregnant, or planning to become pregnant

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01871233

Last Update

April 16 2020

Active Locations (78)

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Page 1 of 20 (78 locations)

Fundacion Cerebro Y Mente

Mendoza, Mendoza Province, Argentina, M5519FNF

Hospital General De Agudos José María Ramos Mejia

Buenos Aires, Argentina, C1221ADC

Buenos Aires, Argentina