The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment

(TTX-CINP-201 Trial)

Recruiting at22 trial locations

Overseen by Samuel Goldlust, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Wex Pharmaceuticals Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of many chemotherapeutic agents including vincristine, paclitaxel, cisplatin, oxaliplatin, bortezomib and ixabepilone. Chemotherapy-induced peripheral neuropathy commonly occurs in greater than 40% of patients. To improve the peripheral neuropathy, the chemotherapy dosing is often either decreased or discontinued potentially affecting tumor responsiveness, prognosis, and survival. There is an unmet medical need for treatment of cancer patients with chemotherapy induced neuropathic pain (CINP) and the proposed study will investigate the efficacy and safety of multiple dose levels of tetrodotoxin (TTX) versus placebo in moderate to severe neuropathic pain caused by chemotherapy.

Research Team

Samuel Goldlust, MD

Principal Investigator

Hackensack University

Eligibility Criteria

Inclusion Criteria

If female, not of childbearing potential.

Patients with documented neuropathic pain

Cancer Patients who have completed a chemotherapy regimen which included taxanes or platinums (or both) and have no evidence actively progressive disease. Concurrent hormonal therapies are allowed

Treatment Details

Interventions

• Tetrodotoxin (Other)

Participant Groups

Group I: Mid-range dose of Tetrodotoxin (twice daily) Experimental Treatment 1 Intervention

Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.

Group II: Max dose Tetrodotoxin (twice daily) Experimental Treatment 1 Intervention

Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.

Group III: Max dose Tetrodotoxin (once daily) Experimental Treatment 2 Interventions

Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days.

Group IV: Low dose Tetrodotoxin (twice daily) Experimental Treatment 1 Intervention

Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.

Group V: Placebo (twice daily) Placebo Group 1 Intervention

Placebo for injection (1 ml volume), twice a day for four consecutive days.

Who Is Running the Clinical Trial?

Wex Pharmaceuticals Inc.

Lead Sponsor

Trials

6

Recruited

510+

Premier Research Group plc

Industry Sponsor

Trials

65

Recruited

74,200+

John Ratliff

Premier Research Group plc

Chief Executive Officer since 2024

MBA

Dr. Milena Kanova-Petrova

Premier Research Group plc

Chief Medical Officer since 2024

MD