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Neurotoxin

Resiniferatoxin for Chronic Pain

Phase 1 & 2
Waitlist Available
Led By John D Heiss, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects taking certain medications will be counseled to stop taking these at least 7 days before surgery or be given instructions on dosing changes if applicable.
Must be able and willing to undergo an eye examination.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of study
Awards & highlights

Study Summary

This trial is testing whether the research drug RTX is safe and can reduce cancer-induced bone pain.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Specific side effects are not listed here but may include reactions related to anesthesia or sedation during the procedure, discomfort from injections or catheters used during treatment, as well as any general risks associated with invasive medical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to stop or adjust my medication as advised before surgery.
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I am willing and able to have an eye exam.
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I understand and can agree to the study's procedures and risks.
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I have someone to help me with daily tasks until Day 14 of the visit.
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I can assign someone to make decisions for me for research and medical care.
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I am 18 years old or older.
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I experience moderate to severe pain that regular treatments don't relieve.
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I am not currently undergoing any treatments intended to cure my cancer.
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I agree to a pain relief injection that must reduce my pain by at least 30%.
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I am willing to use effective birth control during the study.
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I have severe cancer-related pain in my mid-body to legs that doesn't get better with usual treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7, day 15, day 68, day 188
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7, day 15, day 68, day 188 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To investigate the safety and efficacy of RTX administered intrathecally in subjects with severe refractory pain associated with advanced cancer along with ED100, the MTD, or the maximum dose administered, whichever is achieved first during dose...
Secondary outcome measures
Improved pain relief through the 180-day time point compared to baseline
Improved quality of life
Substantially reduced (20%) concomitant opioid analgesic consumption
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ResiniferatoxinExperimental Treatment1 Intervention
Schedule a maximum of 3 periganglionic DRG injection(s) at contiguous level(s) to treat targeted DRG responsible for chronic CIBP
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resiniferatoxin
2017
Completed Phase 1
~120

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,335 Previous Clinical Trials
648,501 Total Patients Enrolled
1 Trials studying Palliative Care
45 Patients Enrolled for Palliative Care
John D Heiss, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
8 Previous Clinical Trials
5,417 Total Patients Enrolled
1 Trials studying Palliative Care
45 Patients Enrolled for Palliative Care

Media Library

Resiniferatoxin (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT02522611 — Phase 1 & 2
Palliative Care Research Study Groups: Resiniferatoxin
Palliative Care Clinical Trial 2023: Resiniferatoxin Highlights & Side Effects. Trial Name: NCT02522611 — Phase 1 & 2
Resiniferatoxin (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02522611 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots in this trial for participants?

"Clinicaltrials.gov confirms that this medical study, which was initially posted on the 1st of January 2023 and last updated November 18th 2022, is not actively looking for enrollees at present. However, there are 60 other trials in progress right now seeking participants."

Answered by AI

Are there additional investigations into Resiniferatoxin's effects?

"Currently, 4 clinical trials are ongoing concerning the use of Resiniferatoxin. None of these studies have advanced to Phase 3 yet. Despite being primarily administered in Bethesda, Maryland, 11 other sites also offer this treatment option as part of their research."

Answered by AI

How many volunteers are participating in this clinical trial?

"At the moment, this trial is not currently enrolling patients. It was initially posted on January 1st 2023 and its information last updated on November 18th 2022. If you're searching for other studies, there are 56 different clinical trials related to pain that are actively recruiting participants as of now; additionally, 4 Resiniferatoxin-related experiments have open spots available."

Answered by AI

Do I meet the requirements to partake in this exploration?

"This clinical trial actively seeks 30 patients aged 18 or over with intractable, cancer-induced pain in their mid thoracic or lower body who have not responded to conservative therapies (i.e., analgesics, radiotherapy, bisphosphonates). Participants must be healthy enough to tolerate study procedures and abstain from taking aspirin, prophylactic anticoagulants such as Coumadin, heparin or Xarelto for at least seven days prior to surgery. In addition, any individuals currently taking a Factor Xa inhibitor will need an additional haematology consultation. Furthermore candidates cannot undergo curative"

Answered by AI

Is this a novel clinical trial?

"At present, 4 clinical trials for Resiniferatoxin are running across 7 cities in 1 nation. The initial trial began back in 2009 and was sponsored by Sorrento Therapeutics, Inc. This phase-one drug approval included 45 participants and since then two additional studies have been conducted."

Answered by AI

Is enrollment open to individuals over thirty years of age in this experiment?

"According to the trial's requirements, individuals aged 18 - 150 are eligible for participation."

Answered by AI

What desired effects are the investigators hoping to observe from this research trial?

"This medical trial's main purpose is to evaluate the safety and toxicity of a given treatment. Secondary objectives include a 20% decrease in pain intensity at 30, 60, 90, and 180 days post-treatment when compared to baseline scores; an increase in quality of life via the Brief Pain Inventory (BPI); and substantially reduced concomitant opioid analgesic consumption per NRS daily worst score estimates."

Answered by AI
~20 spots leftby Dec 2026