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

NCT00592904 | Completed Phase 2 Results

• 2 other identifiers: E2007-G000-2282007-005495-13
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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).

Conditions

Neuralgia

Keywords

Neuralgia; neuropathy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

• Analysis of Patient Global Impression of Change (PGIC) at Week 48/End of Treatment (EOT)

  Baseline and Week 48

• Mean Change From Baseline in Short Form 36 Item (SF-36) Health Survey: Physical and Mental Component Scores From Baseline to Week 48/EOT

  Baseline and Week 48

Study Arms (1)

1

EXPERIMENTAL

Drug: E2007

Interventions

E2007 DRUG

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).

Also known as: Perampanel

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Unknown Facility

Chicago, Illinois, 60610, United States

Location

MeSH Terms

Conditions

Neuralgia

Interventions

perampanel

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Antonio Laurenza, M. D.

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 14, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: July 1, 2011
• Last Updated: January 21, 2016
• Results First Posted: February 8, 2013

Record last verified: 2015-11

Locations

US (1)