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NCT05695339 · ClinicalTrials.gov registry record · Phase 1
Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain
A Phase 1 study of Morton's Neuroma, sponsored by National Institutes of Health Clinical Center (CC).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05695339: Recruiting Phase 1 study of Morton's Neuroma, sponsored by National Institutes of Health Clinical Center (CC).
NCT05695339 is a Phase 1 study of Morton's Neuroma that is actively recruiting participants, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05695339, a Phase 1 study of Morton's Neuroma, is actively recruiting participants, sponsored by National Institutes of Health Clinical Center (CC).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
-The number of related Adverse Events (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials) experienced between day 0 (injection day) and day 28 post-injection
Conditions Studied
Interventions
- DRUG Resiniferatoxin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-03-13 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 1 |
What NCT05695339 shows while recruiting
NCT05695339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Morton's Neuroma appearing as the primary indexed condition, and to 1 intervention - of which Resiniferatoxin is the first listed.
NCT05695339 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05695339 about?
NCT05695339 is a clinical study titled "Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain". 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. C...
What is the current status of trial NCT05695339?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-03-13. Estimated completion is 2026-12-01.
What conditions does trial NCT05695339 study?
This clinical trial studies the following conditions: Morton's Neuroma.
What interventions are being tested in trial NCT05695339?
The interventions under investigation include: Resiniferatoxin (DRUG).
Who is sponsoring clinical trial NCT05695339?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05695339 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05695339's enrollment target sits among peer trials
24 1521st of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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