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Tetrodotoxin for Neuropathic Pain
Phase 2
Recruiting
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
Timeline
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 belowSelect...
You have ongoing nerve pain from platinum or taxane chemotherapy for at least 3 months.
Select...
You have a score of 4 or higher out of 10 on a pain questionnaire.
Select...
You have finished a certain type of chemotherapy for cancer and your disease is not getting worse.
Select...
You have an Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
Select...
You have had stable moderate to severe nerve pain for at least 14 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 12
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 moreTrial 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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken medications that can cause numbness or tingling in your hands or feet within the last 90 days.You are not expected to live for more than 8 months.You have trouble peeing.You have been diagnosed with Major Depressive Disorder.You have uncontrolled asthma, low oxygen levels, or need oxygen therapy.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 a history of nerve problems due to something other than certain types of chemotherapy.You have been diagnosed with cancer that has spread to your bones before entering the trial.You have used lidocaine or similar drugs for heart rhythm within the past 30 days.You have had Botox injections in the past 3 months or plan to have them during the study.You need to take anti-nausea medicine regularly.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 been given TTX before joining the study.You are taking a medication that can affect your heart's electrical activity, unless you have been on a stable dose for at least 60 days before the study starts.You have a history of relying on drugs, including prescription drugs, or have tested positive for drugs in your urine.You have had stable moderate to severe nerve pain for at least 14 days.You have certain heart rhythm or electrical problems shown on your screening heart test.You have problems with moving your neck or throat muscles.You have used opioids in the past two weeks or plan to use them during the study.You have kidney problems and your GFR test result is less than 50 mL/min/1.73 m2.You haven't fully recovered from side effects of chemotherapy except for mild nerve pain.Your blood tests show low levels of hemoglobin, white blood cells, or platelets, or your liver function tests are abnormal.You are currently taking certain types of antidepressant or anticonvulsant medications.You have a history of drinking too much alcohol, including binge drinking, in the past year, or you drink more than 3 units of alcohol every day.You have nerve pain from platinum or taxane chemotherapy for at least 3 months.If you can have children, you need to use reliable birth control during the study and for 30 days after it ends. You'll also need to take a pregnancy test before starting the study.You have not had sexual intercourse since your last period.You have long-term nerve pain from certain types of chemotherapy.You have a score of 4 or higher on a pain questionnaire.You have had nerve pain from certain chemotherapy drugs for at least 3 months.You must use two forms of birth control, like condoms or a diaphragm with sperm-killing gel, to prevent pregnancy.You are currently using an intrauterine device for birth control.If you score 4 or higher on a specific pain questionnaire, you cannot participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Tetrodotoxin for injection
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
California
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?
0
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