Chemotherapy-Induced Peripheral Neuropathy Clinical Trial
Official title:
A Double Blind, Placebo Controlled Study of the Effect of 330 mg QD of TRO19622 in the Treatment of Chemotherapy Induced Peripheral Neuropathy
The purpose of this study is to test the effect of TRO19622 on peripheral neuropathy scores after 6 weeks treatment and is based on the separate assessment of pain and dysesthesia scores.
Chemotherapy Induced Peripheral Neuropathy represents a frequent and invalidating side
effect that requires treatment. Current treatment options are multiple, but none have yet
demonstrated efficacy in double-blind clinical trials .
This study will provide information useful to determine the potential of TRO19622 to relieve
both pain and dysesthesia which are the most common symptoms experienced by patients with
peripheral neuropathy following taxane chemotherapy.
At the start of the study, patients will be randomized to one of two groups : TRO19622 (330
mg QD or placebo once a day).
Each treatment will be administered for 6 weeks. Additionally, patients will have the option
to continue treatment for another 6 weeks duration.
Treatment will be administered under double-blind conditions. The product under evaluation
will be administered to patients receiving the standard of care for CIPN.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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