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Neurotoxin

Resiniferatoxin for Morton's Neuroma Pain

Phase 1
Recruiting
Led By Andrew J Mannes, M.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Both male and female participants are eligible for study evaluation with no exclusions for any racial/ethnic groups
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between day 21 and 28
Awards & highlights

Study Summary

This trial tests a drug to relieve Morton's neuroma pain in people aged 18+ who have tried other treatments. Tests, injections, phone calls & follow-ups will be done.

Who is the study for?
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.Check my eligibility
What is being tested?
The trial tests resiniferatoxin (RTX), a new drug injected into the foot to manage severe pain from Morton's neuroma. Participants will undergo screening, receive RTX treatment, and have follow-up calls and clinic visits to monitor their condition and any changes in their foot pain.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as swelling or infection, allergic responses due to sensitivity to ingredients like capsaicin found in chili peppers, general discomfort or worsening of foot pain temporarily after injection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will use effective birth control methods for a month after getting RTX treatment.
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I am eligible regardless of my gender or race.
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I am 18 years old or older.
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My foot pain from Morton's neuroma hasn't improved with standard painkillers or injections.
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I have severe foot pain from Morton's neuroma, rating 5 or higher on a pain scale.
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I have been diagnosed with a painful condition in my foot known as Morton's neuroma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between day 21 and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and between day 21 and 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DLT or the highest dose
The number of related Adverse Events
Secondary outcome measures
Change in average worst pain (NRS)
Change in neuropathic pain score
Change in pain interference

Trial Design

1Treatment groups
Experimental Treatment
Group I: ResiniferatoxinExperimental Treatment1 Intervention
Resiniferatoxin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resiniferatoxin
2017
Completed Phase 1
~120

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor
383 Previous Clinical Trials
883,462 Total Patients Enrolled
Andrew J Mannes, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
3 Previous Clinical Trials
140 Total Patients Enrolled

Media Library

Resiniferatoxin (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05695339 — Phase 1
Morton's Neuroma Research Study Groups: Resiniferatoxin
Morton's Neuroma Clinical Trial 2023: Resiniferatoxin Highlights & Side Effects. Trial Name: NCT05695339 — Phase 1
Resiniferatoxin (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05695339 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Resiniferatoxin received authorization from the FDA yet?

"Our team at Power classified Resiniferatoxin's safety as a 1, due to the Phase 1 trial designation and limited evidence of both efficacy and safety."

Answered by AI

Is there currently an open call for participants in this research?

"According to clinicaltrials.gov, this trial has ceased recruiting participants; its last update was on the 26th of January 2023. However, 21 other medical studies are actively enrolling patients at present time."

Answered by AI
~16 spots leftby Dec 2025