Last updated on May 2017

3VM for Treatment of Post Herpetic Neuralgia


Brief description of study

A double-blind, placebo-controlled, crossover, proof of concept study for the use of 3VM1001 Cream, 2g three times daily, for treatment of chronic pain associated with post herpetic neuralgia (PHN) compared to the inactive vehicle as a placebo.

Detailed Study Description

The study is a double-blind, placebo-controlled, crossover, proof of concept study for the use of 3VM1001 Cream, 2g three times daily, for the treatment of chronic pain associated with post herpetic neuralgia (PHN) compared to the inactive vehicle as a placebo. A maximum of 30 subjects will be enrolled. Subjects will self-treat for 5 days followed by a five day washout period; and will then crossover and self-treat for a ten day period. The first treatment will be randomly determined to be active or placebo cream followed by washout and then treatment with the other treatment option. The sequence is either Active-Washout-Placebo or Placebo-Washout-Active. Subjects will self-treat with 2g of cream three times daily for ten days; morning, 6-8 hours later, and at bedtime (60g total exposure to cream). The active pharmaceutical ingredient is copper. The proposed doses in the study are less than 2% of the upper limit of the RDA (0.9 mg/day, upper limit 10mg/day). Rescue medication is acetaminophen, 325mg tablets, one to two tablets per dose, every six hours, as needed, up to six tablets (1 ,950 mg/24 hour day). Subjects who have been on a stable, approved dose of gabapentin are eligible for enrollment, but are required to continue their gabapentin dose regimen throughout the study.

Clinical Study Identifier: NCT03142178

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Mark Freed, MD

Medex Healthcare Research, Inc.
Chicago, IL United States
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Michael Reshak, MD

Medex Healthcare Research, Inc.
Saint Louis, MO United States
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James Greenwald, MD

Medex Healthcare Reasearch, Inc.
New York, NY United States
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