Clinical trial NCT00592904: Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Neuralgia
Keywords: Neuralgia
neuropathy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-14
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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:

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.

Primary outcomes:
measure: Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.
timeFrame: Baseline and Week 48
measure: Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.
timeFrame: Baseline and Week 48
measure: Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48
timeFrame: Baseline and Week 48
Secondary outcomes:
measure: Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)
timeFrame: Baseline and Week 48
measure: Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT
timeFrame: Baseline and Week 48
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
Study officials:
affiliation: Eisai Inc.
name: Antonio Laurenza, M. D.
role: STUDY_DIRECTOR
References: