Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05695339
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-01-21
Brief Title:
Resiniferatoxin for the Management of Refractory Morton s Neuroma Pain
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Open Label Clinical Trial Using Resiniferatoxin A Non-Opioid Medication For the Management of Refractory Mortons Neuroma Pain
Status:
RECRUITING
Status Verified Date:
2024-09-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Study Description
This is an interventional protocol to determine the safety and tolerability of resiniferatoxin RTX for treatment of pain from Mortons neuroma with a single ultrasound-guided perineural injection of RTX It is hypothesized that RTX will provide a long-lasting reduction of the intensity of spontaneous and evoked pain and improve daily function without interfering with other sensory modalities or motor function The safety and efficacy of the interventional procedure will be assessed during the trial The 33 design of RTX treatment will be used to assess safety and determine the Dose Limiting Toxicity DLT Pre- and post-procedure pain intensity assessments including graded interference of pain with daily function and graded descriptors of neuropathic pain will be performed to assess efficacy This protocol is intended to test RTX as a new method for long-term relief of refractory Morton s neuroma pain Potentially this new treatment will reduce the need for radical procedures to treat unrelenting Morton s neuroma pain
Objectives
Primary Objective
-To determine the safety and tolerability of resiniferatoxin RTX for treatment of pain from Mortons neuroma
Secondary Objective
-To determine the efficacy of RTX intervention on pain intensity interference of pain with daily function and incidence and intensity of neuropathic qualities of pain
Endpoints
Primary Endpoint
-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
Secondary Endpoints
Change in average worst pain NRS between day 21 and day 28 compared to baseline average worst pain
Change in pain interference on day 28 compared to screening preinjection using PROMIS pain tools
Change in neuropathic pain score on day 28 compared to screening preinjectionusing painDETECT
This is an interventional protocol to determine the safety and tolerability of resiniferatoxin RTX for treatment of pain from Mortons neuroma with a single ultrasound-guided perineural injection of RTX It is hypothesized that RTX will provide a long-lasting reduction of the intensity of spontaneous and evoked pain and improve daily function without interfering with other sensory modalities or motor function The safety and efficacy of the interventional procedure will be assessed during the trial The 33 design of RTX treatment will be used to assess safety and determine the Dose Limiting Toxicity DLT Pre- and post-procedure pain intensity assessments including graded interference of pain with daily function and graded descriptors of neuropathic pain will be performed to assess efficacy This protocol is intended to test RTX as a new method for long-term relief of refractory Morton s neuroma pain Potentially this new treatment will reduce the need for radical procedures to treat unrelenting Morton s neuroma pain
Objectives
Primary Objective
-To determine the safety and tolerability of resiniferatoxin RTX for treatment of pain from Mortons neuroma
Secondary Objective
-To determine the efficacy of RTX intervention on pain intensity interference of pain with daily function and incidence and intensity of neuropathic qualities of pain
Endpoints
Primary Endpoint
-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
Secondary Endpoints
Change in average worst pain NRS between day 21 and day 28 compared to baseline average worst pain
Change in pain interference on day 28 compared to screening preinjection using PROMIS pain tools
Change in neuropathic pain score on day 28 compared to screening preinjectionusing painDETECT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000767-CC | None | None | None |