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

Phase 2

Terminated

Conditions: Pain
Peripheral Neuropathy
Neuropathic Pain

Interventions: Drug: Placebo
Drug: Tetrodotoxin

Registration Number: NCT01655823

Lead Sponsor: Wex Pharmaceuticals Inc.

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 125

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
Patients with stable moderate to severe neuropathic pain
Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Patients who are able to complete the study-related questionnaires independently in either English or Spanish.

Exclusion Criteria

History of peripheral neuropathy attributed to any cause other than chemotherapy.
Patients receiving any concurrent agents known to cause peripheral neuropathy within 30 days of Randomization.
Current use of other therapy (ies), including "alternative" therapies, for treatment of peripheral neuropathy within 30 days of Randomization (with the exception of protocol allowed concurrent medications).
Patients who used controlled release opioids within seven days of baseline period or who expect to use controlled release opioids at any time from baseline to end of study.
Patients with abnormal kidney function.
Patients with bone metastases.
Patients scheduled for treatment for their cancer with chemotherapy or radiotherapy between screening and the end of study visit.
Current use of lidocaine and other types of antiarrhythmic drugs within 30 days of Randomization.
Current use of scopolamine and acetylcholinesterase-inhibiting drugs such as physostigmine within 30 days of Randomization.
Current cause of Chemotherapy Induced Neuropathic Pain attributed to Velcade (Bortezomib) or vinca alkaloids or analogues such as vincristine, vinblasine, vinorelbine and vindesine.
Current use of tricyclic antidepressant medication, anticonvulsants and monoamine oxidase inhibitors.
Patients with current uncontrolled asthma or lung disease.
Patients with significant heart disease.
Use of an investigational agent within 30 days prior to screening or is scheduled to receive an investigational drug other than TTX during the course of the study.
Females who are pregnant or nursing

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Max dose Tetrodotoxin (once daily)	Placebo	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.
Placebo (twice daily)	Placebo	Placebo for injection (1 ml volume), twice a day for four consecutive days.
Low dose Tetrodotoxin (twice daily)	Tetrodotoxin	Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Mid-range dose of Tetrodotoxin (twice daily)	Tetrodotoxin	Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Max dose Tetrodotoxin (once daily)	Tetrodotoxin	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.
Max dose Tetrodotoxin (twice daily)	Tetrodotoxin	Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Patient Reported Outcome for Pain at Day 22 to Day 28.	Day 22 to Day 28	The primary efficacy endpoint for Part I was the change from baseline in weekly average NPRS scores at 22 to 28 days after treatment. Baseline was defined as the average of NPRS scores for the last 7 days prior to dosing. Pain was assessed using a Numerical Pain Rating Scale (NPRS) with a range of 0 (no pain) to 10 (extreme pain).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (23): Lalita Pandit
🇺🇸
Fountain Valley, California, United States
Global Research Management
🇺🇸
Los Angeles, California, United States
Innovative Clinical Research
🇺🇸
Los Angeles, California, United States
Medsol Clinical Research Center
🇺🇸
Port Charlotte, Florida, United States
El Camino Cancer Center
🇺🇸
Mountain View, California, United States
University of Texas Southwestern
🇺🇸
Dallas, Texas, United States
St. Vincent's Medical Center
🇺🇸
Bridgeport, Connecticut, United States
Cancer Center of Kansas
🇺🇸
Wichita, Kansas, United States
Jean Brown Research
🇺🇸
Salt Lake City, Utah, United States
Robert Moss
🇺🇸
Fountain Valley, California, United States
Alliance Research Centers
🇺🇸
Laguna Hills, California, United States
Pacific Cancer Care
🇺🇸
Salinas, California, United States
Redwood Regional Medical Group
🇺🇸
Santa Rosa, California, United States
Axcess Medical Research
🇺🇸
Wellington, Florida, United States
Cancer Center of Middle Georgia
🇺🇸
Dublin, Georgia, United States
Center for Cancer and Blood Disorders
🇺🇸
Bethesda, Maryland, United States
Mercy Medical Research Institute
🇺🇸
Springfield, Missouri, United States
St. Louis Cancer Care
🇺🇸
Bridgeton, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center
🇺🇸
Hackensack, New Jersey, United States
New Mexico Oncology Hematology Consultants
🇺🇸
Albuquerque, New Mexico, United States
Signal Point Clinical Research Center
🇺🇸
Middletown, Ohio, United States
Institute of Pain Research
🇺🇸
Oklahoma City, Oklahoma, United States
Gettysburg Cancer Center
🇺🇸
Gettysburg, Pennsylvania, United States