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)

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2008

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: A, 1
  • Np-1 cream and placebo gabapentin
• Active Comparator: a,2
  • gabapentin caps and placebo cream
• Placebo Comparator: p, 1
  • placebo cream and capsules

Primary Measures

• Improvement in pain intensity
  • Time Frame: 28 Days
    Safety Issue?: Yes

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 Sponsor: EpiCept Corporation

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on August 29, 2008

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