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

• Status: Completed
• Trial end date: 2018-05-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CDA Research Group, Inc.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

1. Devices or therapeutic treatments for pain apart from acetaminophen as a rescue medication

2. Systemic corticosteroids

3. Other Investigational Drugs

4. Chemotherapeutic drugs

5. Immunotherapy

6. Topical products applied to the target skin area

• Subject with history of serious mental illness or psychiatric illness such as dementia, depression, or schizophrenia, that will limit his/her ability to comply with study procedures;

• Subject who is unable to apply, or have a care giver apply, study ointment to the area of most painful skin segments, three times daily, once within 2 hours of waking, once mid-afternoon, and once prior to bedtime;

• Subject who has participated in any other investigational study within 60 days prior to screening;

• Subject who is employed by the Sponsor, study staff, and their families; or

• Subject who has any condition that would make him/her, in the opinion of the investigator or Sponsor, unsuitable for the study.