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An Extended Access Program (EAP) for Perampanel

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ClinicalTrials.gov Identifier: NCT02307578
Expanded Access Status : Available
First Posted : December 4, 2014
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
The main objective of this EAP is to ensure that participants participating in Study E2007-G000-332, Study 311 or EAP 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.

Condition or disease Intervention/treatment
Primary Generalized Tonic-Clonic or Partial Onset Seizures Drug: Perampanel

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Study Type : Expanded Access
Official Title: An Extended Access Program (EAP) for Perampanel

Resource links provided by the National Library of Medicine

Drug Information available for: Perampanel


Intervention Details:
  • Drug: Perampanel
    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 332, Study 311, or EAP 401. Doses of perampanel can be adjusted based on clinical judgment.
    Other Name: E2007, Fycompa

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion criteria:

  1. Participants who have completed their participation in Study 332 or Study 311, or who are being rolled over from EAP 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307578


Contacts
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Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com

Locations
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Latvia
Pharmacy, Riga 1st Hospital
Riga, Latvia, LV-1001
Children's Clinical University Hospital
Riga, Latvia, LV-1004
Sponsors and Collaborators
Eisai Inc.

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02307578     History of Changes
Other Study ID Numbers: E2007-G000-409
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: September 2017
Keywords provided by Eisai Inc.:
Perampanel
Fycompa
Primary Generalized Tonic-Clonic Seizures
E2007-G000-332
E2007
Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms