Tetrodotoxin for injection for Chemotherapy-induced Peripheral Neuropathy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Medsol Research, Port Charlotte, FL
Chemotherapy-induced Peripheral Neuropathy+3 More
Tetrodotoxin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

To be eligible for the trial, subjects must have ongoing moderate to severe neuropathic pain related to a prior course of platinum and/or taxane chemotherapy and have no clinical evidence of actively progressive disease. The trial period will comprise a Screening Period (up to 35 Days), a two-week period for the determinations of Baseline pain followed by randomization and 4-day treatment, followed by a 12-week follow up period (12 weeks total after initial treatment), and an End-of-Trial/Follow-up visit, which will occur at Week 13. This is a study to research the effects of the study drug on neuropathic pain compared placebo.

Eligible Conditions

  • Chemotherapy-induced Peripheral Neuropathy
  • Chemotherapy-induced Neuropathic Pain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Chemotherapy-induced Peripheral Neuropathy

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Day 1 to week 12

At week 12
NPRS Pain reduction - at week 12
At week 4
NPRS Pain reduction - at week 4
At week 8
NPRS Pain reduction - at week 8
Baseline to Week 12
Average rescue medication consumed
BPI change
NPSI change
POMS change
Percent of subjects taking Rescue Medication
Week 12
Duration of response
Time to response
at week 12
Patient global impression of change questionnaire
baseline to week 12
AUC up to week 12
NPRS Pain reduction - weekly
Week 12
Subjects with at least 30% reduction in pain
Subjects with at least 50% reduction in pain
weekly until week 12
Proportion of responders (30%/50%)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Chemotherapy-induced Peripheral Neuropathy

Trial Design

2 Treatment Groups

Tetrodotoxin for injection
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group

222 Total Participants · 2 Treatment Groups

Primary Treatment: Tetrodotoxin for injection · Has Placebo Group · Phase 2

Tetrodotoxin for injection
Drug
ActiveComparator Group · 1 Intervention: Tetrodotoxin · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to week 12
Closest Location: Medsol Research · Port Charlotte, FL
Photo of florida 1Photo of florida 2Photo of florida 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Chemotherapy-induced Peripheral Neuropathy
0 CompletedClinical Trials

Who is running the clinical trial?

Wex Pharmaceuticals Inc.Lead Sponsor
5 Previous Clinical Trials
472 Total Patients Enrolled
Walter KorzStudy DirectorCOO

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a female and have not had sexual intercourse for at least 6 months before trial drug administration.
Double barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream).
Subjects with neuropathic pain attributed to platinum and/or taxane chemotherapy for a minimum of 3 months duration from screening.
You are male or female, aged ≥21 years.\n
You are taking hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full Cycle (based on the subject's usual menstrual Cycle period) before trial drug administration.
Male subjects must agree to use adequate birth control from the signature of the informed consent form up until 30 days after the end of the Treatment Period.
Subjects with cancer who have completed a chemotherapy regimen that includes taxanes or platinums (or in combination) and have no clinical evidence of actively progressive disease.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.