Treatment of PHNEarly Phase 1PHNNCT03421613
3VM1001 Cream for the Treatment of Pain Associated With Post Herpetic Neuralgia (PHN)
A Early Phase 1 study testing 3VM1001 in people with Treatment of PHN, run by CDA Research Group, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Treatment of PHN
- What is being tested?
- 3VM1001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Mar 2017to 4 May 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 13Show fewer
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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;
- Devices or therapeutic treatments for pain apart from acetaminophen as a rescue medication
- Systemic corticosteroids
- Other Investigational Drugs
- Chemotherapeutic drugs
- Immunotherapy
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medex Healthcare Research, Inc.
Chicago, Illinois, 60602
Medex Healthcare Reasearch, Inc.
New York, New York, 10036
About this study
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
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.
Read the detailed description
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.
- Conditions
- Treatment of PHN
- Being tested
- 3VM1001, Placebo
- Keywords
- PHN, acute, herpes zoster
- Medical subject headings
- Neuralgia, Postherpetic, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3VM1001Drug
Self treatment 3 times daily for 10 days
PlaceboOther
Cream without investigational drug. Self treatment 3 times daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 25 days total
Secondary outcomes (4)
Adverse Events, serious adverse events, and study discontinuation
Collection of adverse events and the number of subjects discontinuing he study
Measured: 25 days total
Patient Global Expression of change Scale (PGIC) from baseline (day 0) to the end of each study period.
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".
Measured: 25 days total
Change in Patient Global Assessment of Treatment Satisfaction from baseline to the end of each study phase.
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.
Measured: 25 days total
Use of Rescue medication
recording of the use of rescue mediation at each phase of the study.
Measured: 25 days total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start6 Mar 2017
- Primary completion30 Mar 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of PHNStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- CDA Research Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421613
- Sponsor's protocol ID
- 3VM0416
- Acronym
- PHN
- Status last verified
- Jan 2018
- First submitted
- 30 Jan 2018
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03421613
- Acronym / sponsor ID
- PHN / 3VM0416
- Conditions
- Treatment of PHN
- Keywords
- PHN, acute, herpes zoster
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- CDA Research Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Double-blind, Placebo-controlled, Crossover study to evaluate treatment and tolerability of the experimental product for treatment of post herpetic pain.
| Arm | Type | Receives |
|---|---|---|
| 3VM1001 cream | Experimental | Drug: 3VM1001Patients 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. |
| Placebo | Placebo comparator | Other: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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);
Key exclusion criteria (26 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3VM1001Self treatment 3 times daily for 10 days | Drug | 3VM1001 cream |
| PlaceboCream without investigational drug. Self treatment 3 times daily for 10 days | Other | Placebo |
Primary outcome
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.
4 secondary outcomes
Adverse Events, serious adverse events, and study discontinuation
Time frame: 25 days total
Patient Global Expression of change Scale (PGIC) from baseline (day 0) to the end of each study period.
Time frame: 25 days total
Change in Patient Global Assessment of Treatment Satisfaction from baseline to the end of each study phase.
Time frame: 25 days total
Use of Rescue medication
Time frame: 25 days total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Treatment of PHN
Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain
RecruitingPhase 2
A Clinical Trial to Evaluate the Efficacy and Safety of HL-1186 Tablet in the Treatment of Postherpetic Neuralgia
Postherpetic Neuralgia ( PHN )
RecruitingPhase 3
Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia
Diabetic Neuropathy, Neuropathic Pain
RecruitingPhase 2
Y-4 to Treat the Postherpetic Neuralgia
Postherpetic Neuralgia, Y-4
Recruiting
Intradermal Exosomes, Platelet-Rich Plasma, and Steroids for Post-Herpetic Neuralgia
Postherpetic Neuralgia ( PHN )
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 3VM1001 in people with Treatment of PHN, run by CDA Research Group, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time averaged mean in a standard 100 mm visual analog scale (VAS). (time frame: 25 days total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.