Proof of Principle Study Evaluating Gonyautoxins NEURO SERUM, on Chemotherapy-induced Peripheral Neuropathy
Status:
Recruiting
Trial end date:
2023-01-14
Target enrollment:
Participant gender:
Summary
Proof-of-concept study to assess the effects of gonyautoxins (PSP NEURO SERUM) on safety and
tactile sensitivity on patients with chemotherapy-induced peripheral neuropathy (CIPN). This
is a multicenter, prospective proof-of-concept study in patients with solid tumors affected
by CIPN. The study will be divided into two parts: Part 1 will assess the activity and
tolerability of PSP NEURO SERUM and part 2 consists of a randomized cohort that will compare
the activity of PSP NEURO SERUM vs placebo. Part 2 will depend on the results of part 1. If
there are less than 8 responses in part 1, the study will be interrupted, and it will not be
recommended to proceed with part 2. The detailed description of the study will be given only
for part 1.