A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak

Study Overview
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Brief Summary
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The purpose of this study is to determine whether T-62 is effective in providing relief of pain that can occur after an individual experiences a shingles outbreak, which is an infection in adults caused by the same virus that causes chicken pox.

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Flexible Escalating -Dose, Pilot Analgesic Efficacy Study of T-62 in Subjects With Postherpetic Neuralgia

Conditions
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Postherpetic Neuralgia

Intervention / Treatment
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* Drug: T-62


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a clinical diagnosis of Postherpetic Neuralgia (PHN) Experiencing pain for at least 3 months after the healing of shingles rash Has at least a weekly average pain intensity of equal to or greater than 4 out of 10 Females must not be pregnant or breastfeeding and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal Will not consume grapefruit or grapefruit juice during the study Exclusion Criteria: Has a current acute or unstable chronic disease other than Postherpetic Neuralgia (PHN) Has clinically important medical disorder Uses certain types of medications for heart conditions Unwilling/unable to discontinue use of medications for treatment of neuropathic pain Has a history of hypersensitivity to any medication or soy product Has liver or kidney disease Has asthma that required treatment within the last year Has HIV or hepatitis (other than hepatitis A) Has a history of alcohol abuse within the past 2 years Has a history of (within last 2 years) or currently abuses prescription or illegal drugs

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: T-62|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale) |  | During each Treatment Phase Visit | 
| Various pain related assessment |  | During each Treatment Phase Visit | 
| Clinical Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC ) scores |  | At each Treatment Phase Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, intensity, relationship, and seriousness of treatment-emergent AEs by dose and by treatment group. |  |  | 
| Treatment-emergent changes in safety assessments |  |  | 
| Evaluation of T-62 plasma concentrations |  | At various timepoints during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Postherpetic Neuralgia, Neuralgia, Postherpetic, Shingles, Herpes Zoster, Neuropathic Pain