Resiniferatoxin for Chronic Pain

Recruiting at 1 trial location

Overseen By John D Heiss, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Must be taking: Opioids

Must not be taking: Anticoagulants, Factor Xa inhibitors

Disqualifiers: ECG abnormality, Allergy to capsaicin, Coagulopathy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 2-4 days

30 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain medications like aspirin, non-steroidal anti-inflammatory drugs, or vitamin E at least 7 days before surgery. If you're on a blood thinner like Xarelto, you might need to adjust your dose or consult a specialist. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

How is the drug Resiniferatoxin (RTX) unique for treating chronic pain?

Resiniferatoxin (RTX) is unique because it targets specific pain pathways by acting on nerve cells that transmit pain signals, potentially providing relief for chronic pain conditions where other treatments may not be effective. Unlike many pain medications that work broadly, RTX offers a more targeted approach, which could lead to fewer side effects. ^{1 2 3 4 5}

What is the purpose of this trial?

Background: Cancer-induced bone pain (CIBP) is common in people with cancer. Bone cancer can also lead to anxiety, depression, and reduced mobility and quality of life. Researchers believe a research drug called resiniferatoxin (RTX) may be able to help. Objective: To learn whether RTX is safe and can reduce cancer induced bone pain. Eligibility: People ages 18 and older with CIBP that is not relieved by standard treatments Design: Participants will have up to 6 outpatient visits over about 7 months. These will include: Medical history Physical exam Blood and urine tests. Thermal testing: a disk placed on the skin to test ability to sense temperature in and around the area of pain Chest x-ray EKG: stickers are placed on the chest to measure heart signals ECG: measures electrical activity of the heart Participants will have 1 inpatient visit lasting 2-4 days. This will include: Catheter inserted into a vein in the arm. They are given anesthesia, sedation, and x-ray contrast. A needle is passed through the skin of the back to inject the RTX. Participants will keep a log of the pain medications they take after surgery. Participants will be called 1 week and 2, 3, and 4 months after the injection. Participants will be mailed surveys and questionnaires to complete 2, 3, and 4 months after the injection.

Research Team

John D Heiss, M.D.

Principal Investigator

National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria

Adults over 18 with severe bone pain due to cancer, not relieved by standard treatments. Participants must be in stable health, able to undergo medical procedures and willing to stop certain medications before surgery. Women of childbearing age and men with partners of childbearing potential must use contraception.

Inclusion Criteria

I am willing to stop or adjust my medication as advised before surgery.

Formal review of the subject's medical records and written approval for his/her inclusion in the study by 3 separate persons.

I am willing and able to have an eye exam.

Exclusion Criteria

Subjects must not have an allergy or hypersensitivity to certain substances.

You should not have any spinal cord or spinal space issues that could make it risky to insert a needle.

Your electrolyte levels must be normal or can be fixed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive periganglionic DRG injection(s) of RTX under fluoroscopic guidance

2-4 days

1 inpatient visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Up to 6 outpatient visits, plus phone calls and mailed surveys

Long-term follow-up

Participants' pain relief and opioid consumption are assessed at multiple time points

180 days

Treatment Details

Interventions

• Resiniferatoxin

Trial Overview The trial is testing Resiniferatoxin (RTX) for reducing severe cancer-induced bone pain. It involves outpatient visits for tests like EKG and thermal testing, a short hospital stay for RTX injection, keeping a medication log post-surgery, and completing surveys after the treatment.

Participant Groups

Group I: Resiniferatoxin Experimental Treatment 1 Intervention

Schedule a maximum of 3 periganglionic DRG injection(s) at contiguous level(s) to treat targeted DRG responsible for chronic CIBP

Who Is Running the Clinical Trial?

National Institute of Neurological Disorders and Stroke (NINDS)

Lead Sponsor

Trials

1,403

Recruited

655,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Intravesical resiniferatoxin for the treatment of storage lower urinary tract symptoms in patients with either interstitial cystitis or detrusor overactivity: a meta-analysis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Single dose of rituximab causing organising pneumonia in a patient with B-cell lymphoproliferative disorder. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Rituximab-induced interstitial lung disease: five case reports. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Serious infection risk after 1 year between patients with rheumatoid arthritis treated with rituximab or with a second TNFi after initial TNFi failure: results from The British Society for Rheumatology Biologics Register for Rheumatoid Arthritis. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Rituximab use in pediatric systemic lupus erythematosus: Indications, efficacy and safety in an Indian cohort. [2022]