A Randomized, Double-Blind, Dose-Finding, Placebo Controlled, Phase II Multicenter Study of Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Change from Baseline in patient reported outcome for pain at Day 22 to Day 28.
To identify up to two doses/regimens of Tetrodoxin (TTX) to bring forward to Part II for further evaluation.
Day 22 to Day 28
No
United States: Food and Drug Administration
TTX-CINP-201
NCT01655823
July 2012
December 2015
Name | Location |
---|---|
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 |