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

Pain Clinical Trial

— TTX-CINP-201  

Official title:

A Randomized, Double-Blind, Dose-Finding, Placebo Controlled, Phase II Multicenter Study of Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01655823
• Other study ID #: TTX-CINP-201
• Status: Terminated
• Phase: Phase 2
• Start date: July 2012
• Est. completion date: February 11, 2015

Study information

• Verified date: October 2018
• Source: Wex Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: February 11, 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Pain
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Drug:
• Placebo
Sham treatment acting as control arm
• Tetrodotoxin
Comparison of different dosages of Tetrodotoxin

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Wex Pharmaceuticals Inc.	Premier Research Group plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Patient Reported Outcome for Pain at 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).	Day 22 to Day 28