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

NCT01655823 | Terminated Phase 2 Results DMC

• 1 other identifier: TTX-CINP-201
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 23

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.

Conditions

Pain; Peripheral Neuropathy; Neuropathic Pain

Keywords

Pain; Puffer fish; Tetrodotoxin; TTX; Neuropathy; Chemotherapy; WEX Pharmaceuticals

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Placebo (twice daily)

PLACEBO COMPARATOR

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

Drug: Placebo

Low dose Tetrodotoxin (twice daily)

EXPERIMENTAL

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

Drug: Tetrodotoxin

Mid-range dose of Tetrodotoxin (twice daily)

EXPERIMENTAL

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

Drug: Tetrodotoxin

Max dose Tetrodotoxin (once daily)

EXPERIMENTAL

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.

Drug: Placebo; Drug: Tetrodotoxin

Max dose Tetrodotoxin (twice daily)

EXPERIMENTAL

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

Drug: Tetrodotoxin

Interventions

Placebo DRUG

Sham treatment acting as control arm

Also known as: placebo for injection

Max dose Tetrodotoxin (once daily); Placebo (twice daily)

Tetrodotoxin DRUG

Comparison of different dosages of Tetrodotoxin

Also known as: TTX for injection

Low dose Tetrodotoxin (twice daily); Max dose Tetrodotoxin (once daily); Max dose Tetrodotoxin (twice daily); Mid-range dose of Tetrodotoxin (twice daily)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wex Pharmaceuticals Inc.: lead
• Premier Research: collaborator

Study Sites (23)

Lalita Pandit

Fountain Valley, California, 92708, United States

Location

Robert Moss

Fountain Valley, California, 92708, United States

Location

Alliance Research Centers

Laguna Hills, California, 92653, United States

Location

Global Research Management

Los Angeles, California, 90027, United States

Location

Innovative Clinical Research

Los Angeles, California, 90603, United States

Location

El Camino Cancer Center

Mountain View, California, 94040, United States

Location

Pacific Cancer Care

Salinas, California, 93901, United States

Location

Redwood Regional Medical Group

Santa Rosa, California, 95403, United States

Location

St. Vincent's Medical Center

Bridgeport, Connecticut, 06606, United States

Location

Medsol Clinical Research Center

Port Charlotte, Florida, 33952, United States

Location

Axcess Medical Research

Wellington, Florida, 33414, United States

Location

Cancer Center of Middle Georgia

Dublin, Georgia, 31021, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

St. Louis Cancer Care

Bridgeton, Missouri, 63044, United States

Location

Mercy Medical Research Institute

Springfield, Missouri, 65807, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, 87103, United States

Location

Signal Point Clinical Research Center

Middletown, Ohio, 45042, United States

Location

Institute of Pain Research

Oklahoma City, Oklahoma, 73104, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390-9179, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Pain; Peripheral Nervous System Diseases; Neuralgia

Interventions

Injections; Tetrodotoxin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Marine Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Mehran Kavoosi
• Organization: Wex Pharmaceuticals

mehrank@wexpharma.com

6046767900

Study Officials

• Samuel Goldlust, MD

  Hackensack University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: August 2, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: February 11, 2015
• Last Updated: October 30, 2018
• Results First Posted: October 30, 2018

Record last verified: 2018-10

Locations

US (23)