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NCT02522611 · ClinicalTrials.gov registry record · Phase 1

Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain

A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Not yet
Registry status
Phase 1
Development phase
30
Enrollment target

NCT02522611: Clinical Trial Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

NCT02522611 is a Phase 1 study that has not yet begun recruiting, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02522611, a Phase 1 study, has not yet begun recruiting, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

NOT YET RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

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.

Primary Outcome

The primary study outcome measures are related to safety and toxicity of the investigational agent. The primary study outcome measures are: DLT MTD of RTX

Interventions

  • DRUG Resiniferatoxin

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-06-27
Est. Completion 2026-12-01
Phase Phase 1

What is known before NCT02522611 opens enrollment

NCT02522611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 1 intervention - of which Resiniferatoxin is the first listed.

NCT02522611 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02522611 about?

NCT02522611 is a clinical study titled "Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain". 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 an...

What is the current status of trial NCT02522611?

This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-06-27. Estimated completion is 2026-12-01.

What interventions are being tested in trial NCT02522611?

The interventions under investigation include: Resiniferatoxin (DRUG).

Who is sponsoring clinical trial NCT02522611?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02522611's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02522611, the US trial registry maintained by the National Library of Medicine. NCT02522611 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.