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Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00700310
First received: June 17, 2008
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
Results First Received: October 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Refractory Partial Seizures
Interventions: Drug: perampanel
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
Perampanel 2mg Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
Perampanel 4mg Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
Perampanel 8 mg Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)

Participant Flow:   Overall Study
    Placebo     Perampanel 2mg     Perampanel 4mg     Perampanel 8 mg  
STARTED     187     180     174     171  
COMPLETED     166     154     158     145  
NOT COMPLETED     21     26     16     26  
Adverse Event                 6                 10                 5                 11  
Lost to Follow-up                 4                 1                 0                 1  
Withdrawal by Subject                 8                 9                 8                 8  
Lack of Efficacy                 0                 3                 0                 1  
Administrative/Other                 1                 3                 1                 3  
Randomized, Not Treated                 2                 0                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
Perampanel 2mg Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase)
Perampanel 4mg Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks)
Perampanel 8 mg Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks)
Total Total of all reporting groups

Baseline Measures
    Placebo     Perampanel 2mg     Perampanel 4mg     Perampanel 8 mg     Total  
Number of Participants  
[units: participants]
 		  185     180     172     169     706  
Age, Customized  
[units: Participants]
 		         
<18 Years     14     21     13     12     60  
18-64 Years     169     156     158     153     636  
>64 Years     2     3     1     4     10  
Gender [1]
[units: participants]
 		         
Female     90     95     84     92     361  
Male     95     85     88     77     345  
Race/Ethnicity, Customized [2]
[units: Participants]
 		         
White     119     119     105     116     459  
Asian     34     35     37     28     134  
Chinese     31     25     29     25     110  
Other     1     1     1     0     3  
[1] The number of participants started is not consistant with the number of Baseline Participants due to 6 participants who were randomized in the study, but not treated with stduy drug.
[2] Race



  Outcome Measures
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1.  Primary:   Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)   [ Time Frame: Baseline (Pre-randomization) through Week 19 ]
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2.  Secondary:   Responder Rate   [ Time Frame: Baseline (Pre-randomization) through Week 19 ]
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3.  Secondary:   Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)   [ Time Frame: Baseline (Pre-randomization) through Week 19 ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Eisai Inc.
Organization: Eisai Call Center
phone: 888-422-4743


No publications provided by Eisai Inc.

Publications automatically indexed to this study:


Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00700310     History of Changes
Other Study ID Numbers: E2007-G000-306
Study First Received: June 17, 2008
Results First Received: October 23, 2012
Last Updated: October 23, 2012
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration