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Proof of Principle Study Evaluating Gonyautoxins NEURO SERUM, on Chemotherapy-induced Peripheral Neuropathy

NCT05052398 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-02-01

No results posted yet for this study

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.

Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Interventions

DRUG

PSP NEURO SERUM

PSP NEURO SERUM is a topical product that contains a concentration of Paralytic Shellfish Toxins of 10 micrograms/mL of equivalent of Gonyautoxin 2/3. Each patient will apply 1 g of PSP NEURO SERUM in their hands, three times a day.

DRUG

Placebo PSP NEURO SERUM

Placebo PSP NEURO SERUM is the same topical product as PSP NEURO SERUM without the active ingredient. Each patient will apply 1 g of Placebo PSP NEURO SERUM in their hands, three times a day.

Sponsors & Collaborators

  • Oncoclínicas

    collaborator INDUSTRY

  • Algenis SpA

    lead INDUSTRY

Principal Investigators

  • Mariane Fontes, MD · Oncoclínicas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-14
Primary Completion
2024-07-11
Completion
2025-07-14

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05052398 on ClinicalTrials.gov