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A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00903786
First Posted: May 18, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
  Purpose
The purpose of this trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.

Condition Intervention Phase
Refractory Partial Seizures Drug: perampanel Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)

Resource links provided by NLM:


Further study details as provided by Eisai Inc. ( Eisai Co., Ltd. ):

Primary Outcome Measures:
  • Number of patients with adverse events as a measure of safety [ Time Frame: 4 weeks, 8 weeks, 16 weeks and every 12 weeks till approval ]

Secondary Outcome Measures:
  • Evaluation of patient diaries for seizures [ Time Frame: 4 weeks, 8 weeks, 16 weeks and every 12 weeks till approval ]

Enrollment: 21
Actual Study Start Date: June 17, 2009
Study Completion Date: October 31, 2016
Primary Completion Date: August 8, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perampanel 2 mg Drug: perampanel
Patients will receive the same oral dosage (2 mg up to 12 mg once daily before bedtime) as used in the maintenance period of Study 231.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patients who consent to the study entry on their free will before starting any trial-related activities.
  2. Patients who participated in Study 231 and completed the required evaluation period (10 weeks).
  3. Patients who are certainly and voluntarily able to participate in this study and record their seizures by themselves or have family members or caregivers (or nurses, if hospitalized) record the seizures. Patients who wish to continue perampanel treatment and necessitate receiving the long- term administration judged by the investigator or sub-investigator.

Exclusion criteria:

  1. Pregnant or lactating women, women of child-bearing potential, women willing to become pregnant.
  2. Patients who are ineligible judged by the investigator or sub investigator in light of medical history or complication at enrollment in treatment period.
  3. Patients who operate heavy equipment or drive should not be recruited into the study.
  4. Patients who are ineligible for study entry judged by the investigator or sub-investigator.
  Contacts and Locations
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): NCT00903786


Locations
Japan
Kitakyusyu, Fukuoka, Japan
Kobe, Hyogo, Japan
Sendai, Miyagi, Japan
Komatsushima, Tokushima, Japan
Kodaira, Tokyo, Japan
Kyoto, Japan
Nagasaki, Japan
Niigata, Japan
Shizuoka, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Kazunori Saeki Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
  More Information

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT00903786     History of Changes
Other Study ID Numbers: E2007-J081-233
First Submitted: May 15, 2009
First Posted: May 18, 2009
Last Update Posted: October 12, 2017
Last Verified: March 2017

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Seizure
epilepsy

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anticonvulsants