Clinical Trial: 3VM for Treatment of Post Herpetic Neuralgia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Tolerability of 3VM1001 Cream for the Treatment of Pain Associated With Post-Herpetic Neuralgia

Brief Summary: 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 Summary:

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.

Sponsor: CDA Research Group, Inc.

Current Primary Outcome: Time averaged mean in a standard 100 mm Visual Analog Scale (VAS). [ Time Frame: 2 x 10 days, total 20 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Adverse events, Serious adverse events, and study discontinuation [ Time Frame: 2 x 10 days, total 20 days ]
  Collection of Adverse events, Serious adverse events, and study discontinuation over each study period.
• Patient global impression of change scale (PGIC) from baseline to end of each study period. [ Time Frame: 2 x 10 days, total 20 days ]
  This measure is a single-item rating by participants of their improvement with treatment on a 7-point scale that ranges from "very much improved" to "very much worse" with a mid-point of "no-change".
• Change in the global rating of disease for 3VM1001 Cream and placebo from baseline to the end of each study period. [ Time Frame: From screening to end of Visit 2 (10 days) and at Visit 4 (day 20), total 20 days ]
  Change in the global rating of disease for 3VM1001 Cream and placebo from baseline to the end of each study period measured on a 5-point Likert scale, with numerical values recorded by the subjects at Visits 2 and 4.
• Change in Patient Global Assessment of Treatment satisfaction from baseline to the end of each study period. [ Time Frame: From screening Day 0 to the end of each study visit, total 20 days ]
  Subjects will rate their overall satisfaction from baseline (Day 0) to the end of each study period using a 5-point categorical sale.
• Use of rescue medication [ Time Frame: From screening day 0 to end of study, total 20 days ]
  The use of rescue medication for pain

Original Secondary Outcome: Same as current

Information By: CDA Research Group, Inc.

Dates:
Date Received: April 27, 2017
Date Started: April 30, 2017
Date Completion: March 30, 2018
Last Updated: May 4, 2017
Last Verified: April 2017