An Extended Access Program (EAP) for Perampanel

N/ANo Longer AvailableNCT02307578

Eisai Inc.

Overview

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.

Study Type

EXPANDED_ACCESS

Conditions

Primary Generalized Tonic-Clonic or Partial Onset Seizures Lennox Gastaut Syndrome

Interventions

PerampanelDRUG

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.

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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.

Locations (27)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Data from ClinicalTrials.gov

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