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

• ClinicalTrials.gov Identifier: NCT00475904
• Recruitment Status: Completed
• First Posted: May 21, 2007
• Results First Posted: July 6, 2011
• Last Update Posted: July 27, 2011
• Sponsor: EpiCept Corporation
• Information provided by: EpiCept Corporation

Tracking Information

• First Submitted Date: May 17, 2007
• First Posted Date: May 21, 2007
• Results First Submitted Date: April 20, 2011
• Results First Posted Date: July 6, 2011
• Last Update Posted Date: July 27, 2011
• Study Start Date: July 2007
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 25, 2011)

• 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 ]
  Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.
• 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 ]
  Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.

• Original Primary Outcome Measures (submitted: May 18, 2007): Improvement in pain intensity [ Time Frame: 28 Days ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• Brief Summary: 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)
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Post Herpetic Neuralgia
• PHN
• Neuropathy
• Nerve Pain

Intervention

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

Study Arms

• Active Comparator: amitriptyline 4% ketamine 2% cream, placebo capsules
  Np-1 cream and placebo gabapentin
  Intervention: Drug: EpiCept-NP-1 Cream
• Active Comparator: gabapentin capsules, placebo cream
  gabapentin caps and placebo cream
  Intervention: Drug: Gabapentin Capsules
• Placebo Comparator: placebo cream and capsules
  placebo cream and capsules
  Intervention: Drug: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 9, 2009): 360
• Original Estimated Enrollment (submitted: May 18, 2007): 500
• Actual Study Completion Date: June 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT00475904
• Other Study ID Numbers: EPC2007-02
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Stephane Allard, Chief Medical Officer, EpiCept Corporation
• Original Responsible Party: Not Provided
• Current Study Sponsor: EpiCept Corporation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: EpiCept Corporation
• Verification Date: July 2011