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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
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
Diagnosed with one painful Morton's neuroma in the index foot
Must not have
Current presentation of other currently painful pathology of the same foot affected by Morton's neuroma
Active or history of rheumatoid arthritis or peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between day 21 and 28
Awards & highlights
No Placebo-Only Group

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.
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.
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
Select...
I have severe foot pain from Morton's neuroma, rating 5 or higher on a pain scale.
Select...
I have been diagnosed with a painful condition in my foot known as Morton's neuroma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have another painful foot condition besides Morton's neuroma.
Select...
I have or had rheumatoid arthritis or nerve damage in my hands or feet.
Select...
I have skin issues or infections where I might get the study drug injection.
Select...
I have diabetes or peripheral vascular disease, regardless of how well it is managed.
Select...
I had surgery to remove a nerve in my foot due to Morton's neuroma.
Select...
I have more than one Morton's neuroma in my foot that will be treated.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
389 Previous Clinical Trials
30,879,712 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
~16 spots leftby Dec 2025
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