A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)

Official Title: “A Phase II, Double-Blind, Randomized, Placebo-Controlled Non-inferiority Trial of EpiCept™ NP-1 Topical Cream (2% Ketamine / 4% Amitriptyline) vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)”

The purpose of this study is to compare EpiCept™ NP-1 Topical Cream (2% ketamine / 4% amitriptyline) vs. Oral Gabapentin in the treatment of Postherpetic Neuralgia (PHN)

This is a phase II, multicenter, double-blind, randomized, placebo-controlled, parallel group study of NP-1 and oral gabapentin in approximately 500 patients with PHN. Adult patients with pain resulting from PHN and meeting all other eligibility requirements will be screened for 7 days to determine their average daily pain intensity. Qualifying patients will be randomized on a 2:2:1 basis to NP-1, oral gabapentin, or placebo. The treatment period will be 4-Weeks.

Intervention(s) in this Clinical Trial

• Drug: EpiCept-NP-1 Cream
  • ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks
• Drug: Gabapentin Capsules
  • 1800mg/day capsules for 4 weeks
• Drug: placebo
  • placebo cream and caps

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: amitriptyline 4% ketamine 2% cream, placebo capsules
  • Np-1 cream and placebo gabapentin
• Active Comparator: gabapentin capsules, placebo cream
  • gabapentin caps and placebo cream
• Placebo Comparator: placebo cream and capsules
  • placebo cream and capsules

Primary Measures

• Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days.
  • Time Frame: baseline and 28 days
    Safety Issue?: No
• Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin
  • Time Frame: baseline to 28 Days
    Safety Issue?: No

Inclusion Criteria:

• Adult patients with pain for ≥ 3 months following onset of a herpes zoster rash

Exclusion Criteria:

• Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: EpiCept Corporation Industry

Overall Clinical Trial Officials and Contacts

Robert H Dworkin, Ph.D. Principal Investigator University of Rochester  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00475904

Study ID Number: EPC2007-02

ClinicalTrials.gov Identifier: NCT00475904

Health Authority: United States: Food and Drug Administration