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An Extended Access Program for Perampanel

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ClinicalTrials.gov Identifier: NCT01871233
Expanded Access Status : Available
First Posted : June 6, 2013
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

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.


Condition or disease Intervention/treatment
Partial Onset Seizures Drug: Perampanel

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Perampanel


Intervention Details:
  • Drug: Perampanel
    Patients will enter this program on the same dose of perampanel that they were receiving at the end of their participation in Studies 207, 307, or 235. Doses of perampanel and of concomitant anti-epileptic drugs (AEDs) can be adjusted based on clinical judgment. A minimum daily dose permitted will be 12 mg per day. Treatment will be prescribed as long as clinically appropriate according to the judgment of the treating physician and the approved summary of Product Characteristics (SmPC). Tablets will be available in strengths of 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg. Patients will be instructed to take their perampanel tablets once daily, by mouth, before bedtime, and with food.
    Other Name: E2007

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

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): NCT01871233


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

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Sponsors and Collaborators
Eisai Inc.
Investigators
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Study Director: Karen Searle, PhD Eisai Limited

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01871233     History of Changes
Other Study ID Numbers: E2007-G000-401
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: September 2017
Keywords provided by Eisai Inc.:
anti-epileptic drug
Extended Access Program
partial onset seizures
Perampanel
Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anticonvulsants