Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain (NCT05695339) | Clinical Trial Compass
CompletedPhase 1
Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain
United States3 participantsStarted 2025-03-13
Plain-language summary
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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
Both male and female participants are eligible for study evaluation. There are no exclusions for any racial/ethnic groups. Efforts will be made to extend accrual to a representative population. In order to be eligible to participate in this study, an individual must meet all of the following 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.
If…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of related Adverse Events
Timeframe: day 0 (injection day) and day 28 post-injection (end-of-study)
2
DLT or the highest dose
Timeframe: day 0 (injection day) and day 28 post-injection (end-of-study).
Trial details
NCT IDNCT05695339
SponsorNational Institutes of Health Clinical Center (CC)