3VM1001 Cream for the Treatment of Pain Associated With Post Herpetic Neuralgia (PHN)

NCT03421613 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 3VM0416
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

Post-herpetic neuralgia (PHN) is pain following acute herpes zoster; defined as pain lasting longer than 3 months. Current first line management consists of tricyclic anti-depressants and anti-convulsants such as gabapentin and pregabalin. There is an unmet medical need for treatments got topical therapies that demonstrate efficacy without serious side effects.

Conditions

Treatment of PHN

Keywords

PHN, acute, herpes zoster

Outcome Measures

Primary Outcomes (1)

• The time averaged mean in a standard 100 mm visual analog scale (VAS).

  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.

  25 days total

Secondary Outcomes (4)

• Adverse Events, serious adverse events, and study discontinuation

  25 days total

• Patient Global Expression of change Scale (PGIC) from baseline (day 0) to the end of each study period.

  25 days total

• Change in Patient Global Assessment of Treatment Satisfaction from baseline to the end of each study phase.

  25 days total

• Use of Rescue medication

  25 days total

Study Arms (2)

3VM1001 cream

EXPERIMENTAL

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.

Drug: 3VM1001

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

3VM1001 DRUG

Self treatment 3 times daily for 10 days

3VM1001 cream

Placebo OTHER

Cream without investigational drug. Self treatment 3 times daily for 10 days

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PHN for \>3 months;
• Persistent pain for more than 6 months from appearance of herpes zoster rash that is not located above the scalp hairline, or in immediate proximity to mucous membranes (given the low toxicity of copper, PHN affecting the face and neck will be included, but subjects will be trained on avoidance of contact with the eyes or mouth);
• Age 18 years or older;
• Males or females of non-childbearing potential (i.e., 12 months or more of spontaneous amenorrhea, bilateral oophorectomy at least 6 months prior to randomization, hysterectomy with bilateral oophorectomy at least 6 months prior to randomization, or for females over 50 years of age, hysterectomy without bilateral oophorectomy at least 6 months prior to randomization); female subjects of childbearing potential must agree to use contraception (abstinence, birth control pills, rings or patches, diaphragm and spermicide, intrauterine device, condom and vaginal spermicide, surgical sterilization, vasectomy, progestin implant or injection); female partners of childbearing potential of male subjects must agree to use contraception as defined above;
• Persistent neuropathic pain that involves at least 1 dermatome and covering no more than 400 cm2 (the target area);
• Pain intensity in the target area of \> 40mm on a 100mm VAS at screening;
• Intact skin over the target area to be treated;
• Subject agrees to take only the protocol-defined rescue medication as prescribed;
• All concurrent medications taken for any reason except for the treatment of PHN must be stable (dose, frequency) for 14 days;
• Ability to follow protocol with reference to cognitive and situational factors (eg. stable housing, ability to attend visits);
• Ability to read and write English;
• Ability to apply cream without assistance;
• Able to provide written informed consent.

You may not qualify if:

• Subject with systemic disease that would put him/her at an additional risk or limit his/her ability to participate in the study in the opinion of the investigator;
• Subject with known history of human immunodeficiency virus, hepatitis C, or hepatitis B;
• Malignancy other than basal cell carcinoma and carcinoma in situ within the past 2 years;
• Subject who has an active history of alcohol or drug abuse;
• Wilson's disease or other known disorder of copper metabolism;
• Known hypersensitivity or allergy to any component of the product, or to acetaminophen
• Pregnant and breastfeeding women.
• Subject with active herpes zoster lesions;
• Subject with open skin lesions or skin infections in the target area, or conditions over the target area such as eczema or psoriasis;
• Mild pain in the target area, characterized by VAS score of \< 40 mm
• Pain in any other part of the body that could interfere with the patient's assessment of pain in the target area
• Subject who has taken concomitant medications for the treatment of PHN (except acetaminophen or gabapentin) in the last four weeks. If taking gabapentin the dose must have been stable for at least four weeks;
• Treatment with local anesthetic or steroids (including lidocaine patch, transcutaneous electrical nerve stimulation, etc.) in the last 2 weeks or nerve blocks within the last 30 days;
• Subject who has used capsaicin preparations on a regular basis in the 90 days prior to screening and at all in the past two weeks;
• Use of prohibited concomitant medications/therapies;

Sponsors & Collaborators

• CDA Research Group, Inc.: lead

Study Sites (2)

Medex Healthcare Research, Inc.

Chicago, Illinois, 60602, United States

Location

Medex Healthcare Reasearch, Inc.

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Herpes Zoster

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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, .
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, Placebo-controlled, Crossover study to evaluate treatment and tolerability of the experimental product for treatment of post herpetic pain.

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 5, 2018
• Study Start: March 6, 2017
• Primary Completion: March 30, 2018
• Study Completion: May 4, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)