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

EpiCept

Status and phase: Completed; Phase 2

Conditions: PHN; Nerve Pain; Post Herpetic Neuralgia; Neuropathy

Treatments: Drug: EpiCept-NP-1 Cream; Drug: Gabapentin Capsules; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00475904

EPC2007-02

Details and patient eligibility

About

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)

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 3 patient groups, including a placebo group

amitriptyline 4% ketamine 2% cream, placebo capsules

Active Comparator group

Description:

Np-1 cream and placebo gabapentin

Treatment:

Drug: EpiCept-NP-1 Cream

gabapentin capsules, placebo cream

Active Comparator group

Description:

gabapentin caps and placebo cream

Treatment:

Drug: Gabapentin Capsules

placebo cream and capsules

Placebo Comparator group

Description:

placebo cream and capsules

Treatment:

Drug: placebo