Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT01871233
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2020-04-16
First Post:
2013-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Extended Access Program for Perampanel
Sponsor:
Eisai Inc.
Organization:
Study Overview
Official Title:
An Extended Access Program for Perampanel
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: