Pain Clinical Trial
Official title:
A Randomized, Double-Blind, Dose-Finding, Placebo Controlled, Phase II Multicenter Study of Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
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.
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