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Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00592904
First received: January 3, 2008
Last updated: June 26, 2014
Last verified: February 2013
Results First Received: October 23, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neuralgia
Intervention: Drug: E2007

  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
Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
PDN: Prior Treatment of Perampanel All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
PHN: Prior Treatment of Perampanel All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.

Participant Flow:   Overall Study
    Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo     PDN: Prior Treatment of Perampanel     Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo     PHN: Prior Treatment of Perampanel  
STARTED     57     148     27     30  
COMPLETED     32     93     10     19  
NOT COMPLETED     25     55     17     11  
Adverse Event                 15                 25                 13                 5  
Protocol Violation                 1                 1                 0                 1  
Withdrawal by Subject                 4                 16                 1                 2  
Lack of Efficacy                 2                 7                 2                 3  
Physician Decision                 0                 3                 1                 0  
Not specified                 3                 3                 0                 0  



  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
Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
PDN: Prior Treatment of Perampanel All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
PHN: Prior Treatment of Perampanel All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
Total Total of all reporting groups

Baseline Measures
    Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo     PDN: Prior Treatment of Perampanel     Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo     PHN: Prior Treatment of Perampanel     Total  
Number of Participants  
[units: participants]
  57     148     27     30     262  
Age, Customized  
[units: Participants]
         
<65     40     97     9     9     155  
≥65     17     51     18     21     107  
Gender  
[units: participants]
         
Female     28     52     11     22     113  
Male     29     96     16     8     149  
Race/Ethnicity, Customized [1]
[units: Participants]
         
Asian     2     1     0     0     3  
Black     4     11     0     3     18  
White     48     127     26     24     225  
Other     3     9     1     3     16  
[1] Race



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.   [ Time Frame: Baseline and Week 48 ]

2.  Primary:   Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.   [ Time Frame: Baseline and Week 48 ]

3.  Primary:   Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48   [ Time Frame: Baseline and Week 48 ]

4.  Secondary:   Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)   [ Time Frame: Baseline and Week 48 ]

5.  Secondary:   Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT   [ Time Frame: Baseline and Week 48 ]


  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


Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00592904     History of Changes
Other Study ID Numbers: E2007-G000-228, 2007-005495-13
Study First Received: January 3, 2008
Results First Received: October 23, 2012
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency