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Resiniferatoxin for Morton's Neuroma

National Institutes of Health Clinical Center, Bethesda, MD
Morton's NeuromaResiniferatoxin - Drug
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Morton's Neuroma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

2 Primary · 3 Secondary · Reporting Duration: between day 21 and 28

Day 28
Change in neuropathic pain score
Change in pain interference
Day 21
Change in average worst pain (NRS)
Day 28
The number of related Adverse Events
Day 28
DLT or the highest dose

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Resiniferatoxin
1 of 1

Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: Resiniferatoxin · No Placebo Group · Phase 1

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

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: between day 21 and 28

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor
379 Previous Clinical Trials
986,090 Total Patients Enrolled
Andrew J Mannes, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
3 Previous Clinical Trials
140 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with a painful Morton's neuroma in your foot.
You have Morton's neuroma and have tried different types of pain relief, but none of them have worked well enough.
You experience significant foot pain from Morton's neuroma, with an average worst pain score of 5 or more on a 0-10 scale, reported on at least 3 different days during the screening process.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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