Resiniferatoxin for Morton's Neuroma Pain
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are currently receiving another investigational drug or treatment, you must stop it at least one month before participating in this study.
Is resiniferatoxin (RTX) generally safe for use in humans?
Research on resiniferatoxin (RTX) shows it can be effective in reducing pain, but its safety is not fully established, as concerns about its neurotoxicity and safety margin have been raised. Studies in animals have shown it can alleviate pain without affecting movement, but more human safety data is needed.12345
How does the drug resiniferatoxin (RTX) differ from other treatments for Morton's neuroma pain?
Resiniferatoxin (RTX) is unique because it targets and ablates specific pain-generating neurons by activating the TRPV1 receptor, which can lead to long-lasting pain relief. This mechanism is different from other treatments like botulinum toxin, which may not specifically target these pain pathways.12678
Research Team
Andrew J Mannes, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)
Eligibility Criteria
This trial is for adults over 18 in good health with Morton's neuroma, who've tried other pain treatments without relief. They must be willing to follow the study procedures and use effective contraception if of reproductive potential. Excluded are those with allergies to local anesthetics or chili peppers, certain medical conditions, or concurrent investigational drug use.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
RTX is injected into the foot at the site of the nerve pain. Participants receive a shot to numb the area before RTX is administered and are monitored for 4 hours post-injection.
Follow-up
Participants receive up to 5 follow-up phone calls per week to assess foot pain and side effects. They return to the clinic 4 weeks after treatment for repeated tests.
Long-term Follow-up
Participants are monitored for safety and effectiveness after the initial follow-up period.
Treatment Details
Interventions
- Resiniferatoxin (Neurotoxin)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institutes of Health Clinical Center (CC)
Lead Sponsor