Try our beta test site

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: December 17, 2015
Last verified: November 2015
Results First Received: October 23, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neuralgia
Intervention: Drug: E2007

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide 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
No text entered.


  More Information
  Hide More Information

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



Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00592904     History of Changes
Other Study ID Numbers: E2007-G000-228
2007-005495-13 ( EudraCT Number )
Study First Received: January 3, 2008
Results First Received: October 23, 2012
Last Updated: December 17, 2015