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

Phase 2
18 Years
Open (Enrolling)
Pain, Peripheral Neuropathy, Neuropathic Pain

Thank you

Trial Information

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change from Baseline in patient reported outcome for pain at Day 22 to Day 28.

Outcome Description:

To identify up to two doses/regimens of Tetrodoxin (TTX) to bring forward to Part II for further evaluation.

Outcome Time Frame:

Day 22 to Day 28

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2012

Completion Date:

December 2015

Related Keywords:

  • Pain
  • Peripheral Neuropathy
  • Neuropathic Pain
  • Pain
  • Puffer fish
  • Tetrodotoxin
  • TTX
  • Neuropathy
  • Chemotherapy
  • WEX Pharmaceuticals
  • Neuralgia
  • Peripheral Nervous System Diseases



New Mexico Oncology Hematology Consultants Albuquerque, New Mexico  87102
John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey  07601
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Jean Brown Research Salt Lake City, Utah  84124
University of Texas Southwestern Dallas, Texas  75390
Achieve Clinical Research, LLC Tuscaloosa, Alabama  35406
Holy Name Medical Center Teaneck, New Jersey  07666
Mercy Medical Research Institute Springfield, Missouri  65807
Medsol Clinical Research Center Port Charlotte, Florida  33952
Robert Moss Fountain Valley, California  92708
Alliance Research Centers Laguna Hills, California  92653
Global Research Management Los Angeles, California  90027
Axcess Medical Research Wellington, Florida  33414