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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00903786
First received: May 15, 2009
Last updated: February 13, 2014
Last verified: February 2014

May 15, 2009
February 13, 2014
June 2009
October 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Assessment of adverse events, laboratory examinations, vital signs, 12-lead electrocardiograms, and withdrawal questionnaires. [ Time Frame: 52 weeks after administration. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00903786 on ClinicalTrials.gov Archive Site
Evaluation of patient diaries for seizures [ Time Frame: 4 weeks, 8 weeks, 16 weeks and every 12 weeks till approval ] [ Designated as safety issue: No ]
Evaluation of patient diaries for seizures. [ Time Frame: 56 weeks. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)
A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Refractory Partial Seizures
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.
Experimental: Perampanel 2 mg
Intervention: Drug: perampanel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
October 2015
October 2015   (final data collection date for primary outcome measure)

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.
Both
20 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00903786
E2007-J081-233
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Kazunori Saeki Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Eisai Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP