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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
125
Sham treatment acting as control arm
Comparison of different dosages of Tetrodotoxin
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
...and 13 more locations
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).
Time frame: Day 22 to Day 28
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