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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: December 17, 2015
Last verified: November 2015
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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 
[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 study drug.
Race/Ethnicity, Customized [1] 
[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] 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 ]

2.  Secondary:   Responder Rate   [ Time Frame: Baseline (Pre-randomization) through Week 19 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Eisai Inc.
Organization: Eisai Call Center
phone: 888-422-4743


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00700310     History of Changes
Other Study ID Numbers: E2007-G000-306
2007-006169-33 ( EudraCT Number )
Study First Received: June 17, 2008
Results First Received: October 23, 2012
Last Updated: December 17, 2015
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration