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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Post Herpetic Neuralgia, PHN, Neuropathy, Nerve Pain

Intervention / Treatment
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* Drug: EpiCept-NP-1 Cream
* Drug: Gabapentin Capsules
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: amitriptyline 4% ketamine 2% cream, placebo capsules<br>Np-1 cream and placebo gabapentin | Drug: EpiCept-NP-1 Cream<br>* ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks<br>|
| Active Comparator: gabapentin capsules, placebo cream<br>gabapentin caps and placebo cream | Drug: Gabapentin Capsules<br>* 1800mg/day capsules for 4 weeks<br>* Other names: gabapentin, neurontin;|
| Placebo Comparator: placebo cream and capsules<br>placebo cream and capsules | Drug: placebo<br>* placebo cream and caps<br>* Other names: vehicle cream, placebo capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | baseline and 28 days | 
| Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin | 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. | baseline to 28 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Herpetic Neuralgia, PHN, Neuropathy, Nerve Pain, Topical