3VM1001 Cream for the Treatment of Pain Associated With Post Herpetic Neuralgia (PHN) (PHN)
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|ClinicalTrials.gov Identifier: NCT03421613|
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : July 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Treatment of PHN||Drug: 3VM1001 Other: Placebo||Early Phase 1|
Post-herpetic neuralgia (PHN) is defined as pain following acute herpes zoster (AHZ) lasting >3 months. PHN develops in about 10% of patients following an episode of AHZ. 95% of adults ate seropositive for varicella zoster virus antibodies, and are, therefore, at risk for AHZ and PHN. Wider use of AHZ vaccine approved in 2006 may reduce the incidence of PHN. Nevertheless, PHN may be severe and frequently interferes with daily activities and with sleep.
First line management of PHN pain currently is tricyclic anti-depressants and anti-convulsants such as gabapentin and pregabalin, and use of a 5% lidocaine patch. second line therapies include opioid analgesia and topical capsaicin: combinations of topical and systemic therapies may be used as well. These therapies have common side effects of dry mouth, constipation, sedation, urinary retention, nausea, somnolence, dizziness, weight gain and peripheral edema.
there is an unmet medial need for topical therapies that demonstrate efficacy without the significant side effects o the therapies mentioned above. 3VM cream, a low concentration of copper in a cream vehicle may b such a therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Double-blind, Placebo-controlled, Crossover study to evaluate treatment and tolerability of the experimental product for treatment of post herpetic pain.|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||Subjects will be randomized to receive either treatment wih 3VM1001 cream or the comparator daily for 10 days followed by 5 day wash out period before 10 days of treatment with the comparator or investigational treatment, .|
|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: A Proof of Concept Study|
|Actual Study Start Date :||March 6, 2017|
|Actual Primary Completion Date :||March 30, 2018|
|Actual Study Completion Date :||May 4, 2018|
Experimental: 3VM1001 cream
Patients will be randomized to self treat with 2 g of VM1001 cream times daily for ten days, have a five day wash out period and then 10 days of self treatment with the comparator.
Self treatment 3 times daily for 10 days
Placebo Comparator: Placebo
Patients will be randomized to self treat with either active product or placebo comparator thrice daily for 10 days followed by a 5 day wash out period then 10 days of experimental treatment thrice daily for 20 days.
Cream without investigational drug. Self treatment 3 times daily for 10 days
- The time averaged mean in a standard 100 mm visual analog scale (VAS). [ Time Frame: 25 days total ]The time averaged mean of all patient pain scores over each study period; trend over time for each treatment sill be assessed by day of therapy to evaluate any increase or decrease in effect for each study treatment.
- Adverse Events, serious adverse events, and study discontinuation [ Time Frame: 25 days total ]Collection of adverse events and the number of subjects discontinuing he study
- Patient Global Expression of change Scale (PGIC) from baseline (day 0) to the end of each study period. [ Time Frame: 25 days total ]This measure is a single-item rating by participants of their improvement with treatment on a 7-point sale that ranges from "very much improved" to very much worse" with "no change "the mid-midpoint".
- Change in Patient Global Assessment of Treatment Satisfaction from baseline to the end of each study phase. [ Time Frame: 25 days total ]Patient Global Assessment of Treatment Satisfaction from baseline to the end of each study phase. Patients will rate their overall satisfaction with study treatment using a 5-point categorical scale.
- Use of Rescue medication [ Time Frame: 25 days total ]recording of the use of rescue mediation at each phase of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421613
|United States, Illinois|
|Medex Healthcare Research, Inc.|
|Chicago, Illinois, United States, 60602|
|United States, New York|
|Medex Healthcare Reasearch, Inc.|
|New York, New York, United States, 10036|