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Evaluating the 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:
NCT00699972
First received: June 17, 2008
Last updated: January 2, 2013
Last verified: January 2013
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: E2007 (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 6 placebo tablets received daily during both Titration and Maintenance Periods.
Perampanel 8mg Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
Perampanel 12mg Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)

Participant Flow:   Overall Study
    Placebo     Perampanel 8mg     Perampanel 12mg  
STARTED     122     133     135  
COMPLETED     106     114     100  
NOT COMPLETED     16     19     35  
Adverse Event                 7                 9                 24  
Lost to Follow-up                 0                 2                 0  
Withdrawal by Subject                 3                 7                 4  
Lack of Efficacy                 2                 0                 2  
Administrative/Other                 3                 1                 4  
Randomized, Not Treated                 1                 0                 1  



  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 6 placebo tablets received daily during both Titration and Maintenance Periods.
Perampanel 8mg Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8mg daily over 13-weeks)
Perampanel 12mg Perampanel 12mg maximum daily dose (Titration from 2mg to 12mg daily over 6-weeks; Maintenance at 12mg daily over 13-weeks)
Total Total of all reporting groups

Baseline Measures
    Placebo     Perampanel 8mg     Perampanel 12mg     Total  
Number of Participants  
[units: participants]
  121     133     134     388  
Age, Customized [1]
[units: participants]
       
<18 years     14     15     10     39  
18-64 years     102     116     119     337  
>64 years     5     2     5     12  
Gender [1]
[units: participants]
       
Female     67     68     65     200  
Male     54     65     69     188  
Race/Ethnicity, Customized [1]
[units: participants]
       
White     103     115     116     334  
Black or African American     13     6     8     27  
Asian     0     1     1     2  
Chinese     0     1     1     2  
American Indian or Alaska Native     0     4     2     6  
Other     5     6     6     17  
[1] Safety Population used. One subject in Arm 1 and one subject in Arm 3 were randomized, but not treated.



  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


No publications provided by Eisai Inc.

Publications automatically indexed to this study:

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00699972     History of Changes
Other Study ID Numbers: E2007-G000-304
Study First Received: June 17, 2008
Results First Received: October 23, 2012
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration; European Union: European Medicines Agency