Overview

Phase I Open Label Clinical Trial Using Resiniferatoxin, A Non-Opioid Medication, for the Management of Refractory Morton's Neuroma Pain

Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
Study Description: This is an interventional protocol to determine the safety and tolerability of resiniferatoxin (RTX) for treatment of pain from Morton's 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 3+3 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 Morton's 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 BPI-SF. Change in neuropathic pain score on day 28 compared to screening (preinjection)using painDETECT.
Phase:
Phase 1
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)