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

Neuralgia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592904
• Other study ID #: E2007-G000-228
• Secondary ID: 2007-005495-13
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 3, 2008
• Last updated: December 17, 2015
• Start date: January 2008
• Est. completion date: July 2011

Study information

• Verified date: November 2015
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: July 2011
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuralgia
• Neuralgia, Postherpetic

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Short Form-McGill Pain Questionnaire (SF-MPQ): Sensory and Affective Scores, From Baseline to Week 48.	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.	Baseline and Week 48	No
Primary	Mean Change From Baseline in SF-MPQ Visual Analog Scale (VAS): From Baseline to Week 48.	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.	Baseline and Week 48	No
Primary	Mean Change From Baseline in SF-MPQ Current Pain Intensity (CPI): From Baseline to Week 48	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).	Baseline and Week 48	No
Secondary	Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)	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].	Baseline and Week 48	No
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	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.	Baseline and Week 48	No