MedTrace Logo

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

NCT01655823 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2018-10-30

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

DRUG

Placebo

Sham treatment acting as control arm

DRUG

Tetrodotoxin

Comparison of different dosages of Tetrodotoxin

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Wex Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Samuel Goldlust, MD · Hackensack University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-01-31
Completion
2015-02-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01655823 on ClinicalTrials.gov