Phase 3
N=262
Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)
Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT00592904 ↗Enrolled (actual)
262
Serious AEs
13.7%
Results posted
Feb 2013
Primary outcome: Primary: Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48. — -10.5; -8.1; -9.0; -9.8 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- E2007 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48. |
-10.5; -8.1; -9.0; -9.8 | — |
| PRIMARY Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48. |
-43.1; -33.7; -35.9; -35.4 | — |
| PRIMARY Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48 |
-0.9; -1.0; -1.1; -1.3 | — |
| SECONDARY Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT) |
8; 22; 5; 6; 16; 33 | — |
| 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 |
5.48; 5.14; 1.72; 2.18; 0.40; -2.32 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
Each patient must meet all of the following criteria to be enrolled in this study:
- 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.
- 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.
- 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.
- Provide written informed consent prior to entering the study and prior to undergoing any study-related procedures.
- 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:
- Patients who discontinued early for any reason from the preceding double-blind study.
- Patients who have a clinically significant finding(s) that would make them unsuitable for the study in the opinion of the investigator or Sponsor.
Data sourced from ClinicalTrials.gov (NCT00592904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.