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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: October 30, 2015
Last verified: October 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: 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
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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.
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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 
Overall Participants Analyzed 
[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 
[1] Safety Population used. One subject in Arm 1 and one subject in Arm 3 were randomized, but not treated.
Gender [1] 
[Units: Participants]
       
Female   67   68   65   200 
Male   54   65   69   188 
[1] Safety Population used. One subject in Arm 1 and one subject in Arm 3 were randomized, but not treated.
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


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

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: October 30, 2015
Health Authority: United States: Food and Drug Administration; European Union: European Medicines Agency