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Tetrodotoxin for Neuropathic Pain

Phase 2
Research Sponsored by Wex Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with neuropathic pain attributed to platinum and/or taxane chemotherapy for a minimum of 3 months duration from screening
Subjects with a score of 4 or higher out of 10 on the Diagnosing Neuropathic Pain-DN4 Questionnaire at Screening
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upday 1 to week 12
Awards & highlights

Study Summary

This trial is testing the effects of the study drug on neuropathic pain caused by chemotherapy. It will last 13 weeks and participants will be randomly assigned to either the study drug or placebo group.

Eligible Conditions
  • Chemotherapy Induced Neuropathic Pain
  • Peripheral Neuropathy

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have ongoing nerve pain from platinum or taxane chemotherapy for at least 3 months.
You have a score of 4 or higher out of 10 on a pain questionnaire.
You have finished a certain type of chemotherapy for cancer and your disease is not getting worse.
You have an Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
You have had stable moderate to severe nerve pain for at least 14 days.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
NPRS Pain reduction - at week 4
Secondary outcome measures
NPRS Pain reduction - at week 12
NPRS Pain reduction - at week 8
Other outcome measures
AUC up to week 12
Average rescue medication consumed
BPI change
+10 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Tetrodotoxin for injectionActive Control1 Intervention
30 µg, 1 ml SC injection in the thigh or abdomen, twice daily for 4 Days
Group II: PlaceboPlacebo Group1 Intervention
1.0 mL of placebo, SC injection in the thigh or abdomen, twice daily for 4 Days

Find a Location

Who is running the clinical trial?

Wex Pharmaceuticals Inc.Lead Sponsor
5 Previous Clinical Trials
472 Total Patients Enrolled
1 Trials studying Neuropathic Pain
125 Patients Enrolled for Neuropathic Pain
Walter KorzStudy DirectorCOO

Media Library

Single Cycle Tetrodotoxin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05359133 — Phase 2
Neuropathic Pain Research Study Groups: Placebo, Tetrodotoxin for injection
Neuropathic Pain Clinical Trial 2023: Single Cycle Tetrodotoxin Highlights & Side Effects. Trial Name: NCT05359133 — Phase 2
Single Cycle Tetrodotoxin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05359133 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are included in this trial's sample size?

"That is correct. According to records located on clinicaltrials.gov, this research project was created on April 19th 2022 and recently updated three weeks later. It currently requires 222 patients to be recruited from two distinct locations."

Answered by AI

Is enrollment for this research project currently open?

"Verified. According to clinicaltrials.gov, this research study is currently recruiting participants and has been since April 19th 2022 - with the last update made on April 28th 2022. The trial will be enrolling 222 patients from 2 separate sites."

Answered by AI

Could you please discuss the dangers attached to injecting Tetrodotoxin?

"While not yet confirmed by efficacy data, tetrodotoxin for injection has been backed up with safety-related studies and was thus awarded a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Tilda Research
SUNY Upstate Medical University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
~77 spots leftby Oct 2024