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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Both male and female participants are eligible for study evaluation. There are no exclusions for any racial/ethnic groups. Efforts will be made to extend accrual to a representative population. In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Provision of signed and dated informed consent form.

• Ability of subject to understand and the willingness to sign a written informed consent document.

• Must be able to read, write, understand, and complete English-language study-related forms and adequately communicate in English.

• Stated willingness to comply with all study procedures and availability for the duration of the study.

• Male or female, aged 18 and older.

• In good general health as evidenced by medical history.

• Diagnosed with one painful Morton s neuroma in the index foot

• Has not attained satisfactory pain relief with conservative, oral analgesic and at least one kind of injection treatment for Morton s neuroma.

• 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.

• For females of reproductive potential who are sexually active: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one (1) month after administration of RTX.

⁃ If a female, be sterile (surgically or biologically) \* or at least one year postmenopausal\*\*, or have a monogamous partner who is surgically sterile, or have a same sex partner, or if in a heterosexual relationship, must agree to do the following for at least one month after receiving investigational product (IP):

• Practice abstinence, or

• Use at least one of the following medically acceptable methods of birth control:

‣ Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives (must have started a minimum of 1 full cycle, based on the subject s usual menstrual cycle period, before IP dose

⁃ Intrauterine device

⁃ Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream).

∙ Defined as having had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; or having a congenital or acquired condition that prevents childbearing

• Defined as at least 12 months with no menses without an alternative medical cause) \[can be confirmed with follicle stimulating hormone level (FSH) in the post-menopausal range (FSH levels \>=40 milli international units/mL (mIU/mL) at Screening) if the subject is not on hormonal replacement therapy\]

• 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).

⁃ If a male of reproductive potential, unless he has a same sex partner or a partner who is sterile or at least one year post-menopausal, must agree to do the following for at least one month after receiving IP

• practice abstinence from heterosexual activity or

• use (or have their partner use) acceptable contraception (see criterion above) during heterosexual activity

⁃ Male study participants should not donate sperm for 3 months after RTX injection.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Tracy S Williams, R.N.
tracy.williams@nih.gov
(301) 448-5366
Backup
Andrew J Mannes, M.D.
amannes@cc.nih.gov
(301) 594-3427
Time Frame
Start Date: 2025-03-13
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 24
Treatments
Experimental: Resiniferatoxin
Resiniferatoxin
Related Therapeutic Areas
Sponsors
Leads: National Institutes of Health Clinical Center (CC)

This content was sourced from clinicaltrials.gov