The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment
NCT ID: NCT01655823
Last Updated: 2018-10-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
125 participants
INTERVENTIONAL
2012-07-31
2015-02-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo (twice daily)
Placebo for injection (1 ml volume), twice a day for four consecutive days.
Placebo
Sham treatment acting as control arm
Low dose Tetrodotoxin (twice daily)
Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin
Comparison of different dosages of Tetrodotoxin
Mid-range dose of Tetrodotoxin (twice daily)
Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin
Comparison of different dosages of Tetrodotoxin
Max dose Tetrodotoxin (once daily)
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
Sham treatment acting as control arm
Tetrodotoxin
Comparison of different dosages of Tetrodotoxin
Max dose Tetrodotoxin (twice daily)
Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Tetrodotoxin
Comparison of different dosages of Tetrodotoxin
Interventions
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Placebo
Sham treatment acting as control arm
Tetrodotoxin
Comparison of different dosages of Tetrodotoxin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Premier Research Group plc
UNKNOWN
Wex Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Samuel Goldlust, MD
Role: PRINCIPAL_INVESTIGATOR
Hackensack University
Locations
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Lalita Pandit
Fountain Valley, California, United States
Robert Moss
Fountain Valley, California, 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
El Camino Cancer Center
Mountain View, California, United States
Pacific Cancer Care
Salinas, California, United States
Redwood Regional Medical Group
Santa Rosa, California, United States
St. Vincent's Medical Center
Bridgeport, Connecticut, United States
Medsol Clinical Research Center
Port Charlotte, Florida, United States
Axcess Medical Research
Wellington, Florida, United States
Cancer Center of Middle Georgia
Dublin, Georgia, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
St. Louis Cancer Care
Bridgeton, Missouri, United States
Mercy Medical Research Institute
Springfield, 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
University of Texas Southwestern
Dallas, Texas, United States
Jean Brown Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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TTX-CINP-201
Identifier Type: -
Identifier Source: org_study_id
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