Analgesic Efficacy and Safety Study of T-62 in Subjects With Postherpetic Neuralgia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia.

Detailed Description
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Study K862-08-2002 is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia (PHN) and its associated pain. Up to 20 centers in the United States will participate in the trial. Two doses of T-62 and placebo will be evaluated in parallel design. Approximately 130 subjects will be enrolled to complete approximately 100 subjects. Each subject will complete a 7-day Screening Period , a 28-day Treatment Period, and a 14-day Post-Treatment Period. Each subject will complete 8 clinic visits over the course of the study during which procedures and assessments of safety, efficacy, and protocol compliance will be performed.

Official Title
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A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Analgesic Efficacy and Safety 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 Dose 1
* Drug: T-62 Dose 2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria (additional criteria apply): Diagnosis of PHN made by primary treating physician and is experiencing pain for at least 3 months after the healing of a herpes zoster rash. Subject is in general good health. Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control or be surgically sterile or post-menopausal. Double barrier methods and abstinence are the only acceptable birth control methods for this study. Exclusion Criteria (additional criteria apply): Subject has a current acute disease or unstable chronic disease other than post herpetic neuralgia. Subject has a clinically important history of a medical disorder (particularly cardiovascular, neurological [e.g., diabetic neuropathy], respiratory, or hepato-biliary systems [e.g., Gilbert Syndrome]) that would confound and/or interfere with the safety and efficacy evaluations defined in the protocol. Subject is being treated for a medical condition that affects cardiac conduction. Subject's plasma alanine aminotransferase (ALT) aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase (AP) values are not within the normal reference ranges. Subject has a history of asthma requiring management for reactive airway disease in the last year. Subject uses and is unwilling/unable to discontinue use of (A) Lyrica® (pregabalin), Cymbalta® (duloxetine), Neurontin® (gabapentin), topical lidocaine, topical capsaicin, or other medication specifically indicated (i.e., labeled) for the treatment of neuropathic pain, or (B) anticonvulsant medications to control post herpetic neuralgia. Subject currently requires anticonvulsant medications to control seizures.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T-62 100 mg bid<br> | Drug: T-62 Dose 1<br>* Capsule dosage form 100 mg bid<br>|
| Experimental: T-62 200 mg bid<br> | Drug: T-62 Dose 2<br>* Capsule dosage form 200 mg bid<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Capsule dosage form placebo bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain scores from baseline to following treatment. |  | weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories) |  | weekly | 
| Pharmacokinetics |  | weekly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shingles, Neuropathic pain, Analgesia, Postherpetic neuralgia, Varicella Zoster, Pain