RECRUITING

Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain

Conditions

Morton's Neuroma Neuropathic Forefoot Ultra-Sound Guided Common Plantar Digital Nerve Perineural Injection Trpv1 Morton's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Morton s neuroma is an irritation of the nerves that affect the feet. People with this condition may have burning or shooting pain in the balls of their feet. They may also have numbness in adjacent areas. These symptoms may become more frequent and severe over time. The pain may become permanent. Current treatments tend to be short-lived, and they do not work in all people. Better treatments are needed. Objective: To test a study drug, resiniferatoxin (RTX), in people with Morton s neuroma. Eligibility: Healthy people aged 18 and older who have Morton s neuroma and have tried other standard treatments that did not ease their pain. Design: Participants will be involved in the study up to 4 months. They will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have X-rays of their affected feet. They will have tests to assess their pain and how their feet react to touch and changes in temperature. They will complete questionnaires about their pain. RTX is injected into the foot at the site of the nerve pain. Participants will receive a shot to numb the area before the RTX is administered. They will be monitored in the clinic for 4 hours after they receive the RTX. Participants will receive up to 5 follow-up phone calls per week. Each call will take 5 to 10 minutes. They will be asked about their foot pain and whether they have had any side effects from the RTX. Participants will return to the clinic 4 weeks after the treatment. Previous tests will be repeated.

Official Title

Phase I Open Label Clinical Trial Using Resiniferatoxin, A Non-Opioid Medication, For the Management of Refractory Morton's Neuroma Pain

Quick Facts

Study Start:2024-12-09

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05695339

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Provision of signed and dated informed consent form. * Ability of subject to understand and the willingness to sign a written informed consent document. * Must be able to read, write, understand, and complete English-language study-related forms and adequately communicate in English. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female, aged 18 and older. * In good general health as evidenced by medical history. * Diagnosed with one painful Morton s neuroma in the index foot * Has not attained satisfactory pain relief with conservative, oral analgesic and at least one kind of injection treatment for Morton s neuroma. * Exhibits moderate to severe foot pain due to the Morton s neuroma (average worst pain \>= 5 on the 0-10 numeric pain rating scale NRS) as assessed verbally at \>= 3 individual days during prescreening. * For females of reproductive potential who are sexually active: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one (1) month after administration of RTX. * Practice abstinence, or * Use at least one of the following medically acceptable methods of birth control: * Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives (must have started a minimum of 1 full cycle, based on the subject s usual menstrual cycle period, before IP dose * Intrauterine device * Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream). * Defined as having had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; or having a congenital or acquired condition that prevents childbearing * Defined as at least 12 months with no menses without an alternative medical cause) \[can be confirmed with follicle stimulating hormone level (FSH) in the post-menopausal range (FSH levels \>=40 milli international units/mL (mIU/mL) at Screening) if the subject is not on hormonal replacement therapy\] * For males of reproductive potential who are sexually active: use of condoms or other methods to ensure effective contraception with partner for one (1) month after administration of (RTX). * practice abstinence from heterosexual activity or * use (or have their partner use) acceptable contraception (see criterion above) during heterosexual activity	* Pregnancy or lactation. * Has a known allergy or hypersensitivity to chili peppers or capsaicin. * Has a known allergy to local anesthetics. * Has active or history of rheumatoid arthritis or peripheral neuropathy. * Has a prolonged baseline QTc interval exceeding 480 milliseconds. * Current presentation of other currently painful pathology of the same foot affected by Morton s neuroma, including, but not limited to, hallux valgus, plantar fasciitis, hammer toes, metatarsalgia, bursitis. * History of injection and/or ablation treatments treatment in the affected foot up to one month previous to study participation. * History of nerve excision due to Morton s neuroma in the location to be treated with RTX. * Active cutaneous disease, inflammation or infection at the anticipated site of study drug injection. * Has diabetes mellitus or peripheral vascular disease whether poorly managed or stable. * Has more than one Morton s neuroma in the index foot scheduled to receive the treatment intervention. * Other clinically significant condition that might interfere with study participation or greatly increases safety risk to the subject, as judged by the study investigator. * Concurrent treatment with another investigational drug or other intervention within last month. * Cognitive or language difficulties that would impair comprehension or completion of the assessment instruments.

Inclusion Criteria

Exclusion Criteria

* Provision of signed and dated informed consent form.
* Ability of subject to understand and the willingness to sign a written informed consent document.
* Must be able to read, write, understand, and complete English-language study-related forms and adequately communicate in English.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male or female, aged 18 and older.
* In good general health as evidenced by medical history.
* Diagnosed with one painful Morton s neuroma in the index foot
* Has not attained satisfactory pain relief with conservative, oral analgesic and at least one kind of injection treatment for Morton s neuroma.
* Exhibits moderate to severe foot pain due to the Morton s neuroma (average worst pain \>= 5 on the 0-10 numeric pain rating scale NRS) as assessed verbally at \>= 3 individual days during prescreening.
* For females of reproductive potential who are sexually active: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one (1) month after administration of RTX.
* Practice abstinence, or
* Use at least one of the following medically acceptable methods of birth control:
* Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives (must have started a minimum of 1 full cycle, based on the subject s usual menstrual cycle period, before IP dose
* Intrauterine device
* Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream).
* Defined as having had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; or having a congenital or acquired condition that prevents childbearing
* Defined as at least 12 months with no menses without an alternative medical cause) \[can be confirmed with follicle stimulating hormone level (FSH) in the post-menopausal range (FSH levels \>=40 milli international units/mL (mIU/mL) at Screening) if the subject is not on hormonal replacement therapy\]
* For males of reproductive potential who are sexually active: use of condoms or other methods to ensure effective contraception with partner for one (1) month after administration of (RTX).
* practice abstinence from heterosexual activity or
* use (or have their partner use) acceptable contraception (see criterion above) during heterosexual activity

* Pregnancy or lactation.
* Has a known allergy or hypersensitivity to chili peppers or capsaicin.
* Has a known allergy to local anesthetics.
* Has active or history of rheumatoid arthritis or peripheral neuropathy.
* Has a prolonged baseline QTc interval exceeding 480 milliseconds.
* Current presentation of other currently painful pathology of the same foot affected by Morton s neuroma, including, but not limited to, hallux valgus, plantar fasciitis, hammer toes, metatarsalgia, bursitis.
* History of injection and/or ablation treatments treatment in the affected foot up to one month previous to study participation.
* History of nerve excision due to Morton s neuroma in the location to be treated with RTX.
* Active cutaneous disease, inflammation or infection at the anticipated site of study drug injection.
* Has diabetes mellitus or peripheral vascular disease whether poorly managed or stable.
* Has more than one Morton s neuroma in the index foot scheduled to receive the treatment intervention.
* Other clinically significant condition that might interfere with study participation or greatly increases safety risk to the subject, as judged by the study investigator.
* Concurrent treatment with another investigational drug or other intervention within last month.
* Cognitive or language difficulties that would impair comprehension or completion of the assessment instruments.

Contacts and Locations

Study Contact

Tracy S Williams, R.N.

CONTACT

(301) 448-5366

tracy.williams@nih.gov

Andrew J Mannes, M.D.

CONTACT

(301) 594-3427

amannes@cc.nih.gov

Principal Investigator

Andrew J Mannes, M.D.

PRINCIPAL_INVESTIGATOR

National Institutes of Health Clinical Center (CC)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institutes of Health Clinical Center (CC)

Andrew J Mannes, M.D., PRINCIPAL_INVESTIGATOR, National Institutes of Health Clinical Center (CC)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-09

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-12-09

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

Neuropathic
Forefoot
Ultra-Sound Guided
Common Plantar Digital Nerve
Perineural Injection
Trpv1
Morton's Disease

Additional Relevant MeSH Terms

Morton's Neuroma