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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

January 3, 2008
June 26, 2014
January 2008
November 2009   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    Mean change from baseline to open-label study endpoint and other study visits in SF-MPQ scores sensory and affective). SF-MPQ was completed to assess intensity of pain over the past 48 days for all 15 descriptors: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting,tiring-exhausting, sickening, fear-causing, punishing-cruel. Each descriptor was scored by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0-45); higher scores indicated higher intensity of pain.
  • Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48. [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    SF-MPQ VAS consists of a line 0 to 100 millimeters (mm) in length; range is 0 (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain.
  • Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    Mean change from baseline in SF-MPQ (CPI) at study endpoint. Affective score ranges from 0-5. Higher scores indicate more severe pain (0=no pain, 1=mild, 2=discomforting, 3=distressing, 4=horrible, 5=excrutiating).
Efficacy of perampanel treatment in PDN and PHN patients will be assessed with the SF-MPQ as the primary outcome measure. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00592904 on ClinicalTrials.gov Archive Site
  • Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT) [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]
    The PGIC asked subjects to evaluate the change in their overall status compared with the start of open-label treatment on a scale ranging from 1 (very much improved) to 7 (very much worse). [Please note high withdrawl rate during study].
  • 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 ] [ Designated as safety issue: No ]
    Mean change from baseline in SF-36 Item Health Survey Scores at study endpoint. Each component on the SF-36 Item Health Survey is scored from 0-100 with higher scores reflecting better subject status.
PGIC, SF-36, and rate of study discontinuation due to lack of efficacy. Safety: AEs, laboratory assessments, vital signs, physical examinations and 12-lead ECGs, prior and concomitant medications and tolerability of perampanel. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)
A Multi-Center, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)

The purpose of this study is to evaluate the safety, tolerability and continued efficacy of perampanel in patients previously enrolled in double-blind, placebo-controlled studies for Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN).

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neuralgia
Drug: E2007
Perampanel doses will be up-titrated in 2 mg steps at minimum weekly intervals starting at 2 mg daily and up-titrated to 12 mg daily (taken orally).
Other Name: Perampanel
Experimental: 1
Intervention: Drug: E2007
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
262
July 2011
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Each patient must meet all of the following criteria to be enrolled in this study:

  1. Met and continues to meet all inclusion and none of the exclusion criteria for the preceding PDN or PHN study and received study drug or placebo under double-blind conditions.
  2. Completed the preceding double-blind study End of Treatment (EOT) Visit no more than 12 weeks prior to Baseline (Visit 1) for the open-label study. The eligibility status of patients who do not enroll during this 12 week period will be evaluated on a case by case basis via discussion between the Investigator and the Sponsor.
  3. Males and females ≥18 years of age. Female patients should be either of nonchildbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and practicing a medically acceptable method of contraception (e.g., abstinence, a barrier method plus spermicide, or intrauterine device [IUD]) for at least 1 month before the Baseline Visit (Visit 1) and for 1 month after the end of the study (Visit 16). They must also have a negative pregnancy test at Baseline (Visit 1). Female patients using hormonal contraceptives must also be using an additional approved method of contraception (e.g., a barrier method plus spermicide or IUD) throughout the study.
  4. Provide written informed consent prior to entering the study and prior to undergoing any study-related procedures.
  5. Is reliable, willing, and able to cooperate with the study procedures.

Exclusion Criteria:

Patients who meet the following criterion will be excluded from this study:

  1. Patients who discontinued early for any reason from the preceding double-blind study.
  2. Patients who have a clinically significant finding(s) that would make them unsuitable for the study in the opinion of the investigator or Sponsor.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00592904
E2007-G000-228, 2007-005495-13
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Antonio Laurenza, M. D. Eisai Inc.
Eisai Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP