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Tetrodotoxin for Chemotherapy-Induced 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 neuropathic pain attributed to platinum and/or taxane chemotherapy for a minimum of 3 months duration from screening.
Must not have
History of peripheral neuropathy attributed to any cause other than platinum or taxane chemotherapy
Subjects who have received TTX at any time prior to enrolment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to week 12
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.
Who is the study for?
Adults aged 21+ with moderate to severe nerve pain due to chemotherapy (platinum/taxane) for at least 3 months, who are not currently undergoing treatment for cancer progression. Participants must be able to avoid pregnancy and complete questionnaires in English or the local language.
What is being tested?
The trial is testing Tetrodotoxin's effectiveness against neuropathic pain from chemotherapy compared to a placebo. It includes a screening period, two weeks of baseline pain assessment, a four-day treatment phase, and follows up for twelve weeks.
What are the potential side effects?
Potential side effects may include numbness or tingling sensations, nausea, headache, weakness or dizziness. Since Tetrodotoxin affects nerve function, it could potentially cause changes in sensation or motor skills.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have nerve pain from chemotherapy for at least 3 months.
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I have nerve pain from chemotherapy for at least 3 months.
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I have nerve pain from chemotherapy for at least 3 months.
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I am 21 years old or older.
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I have nerve pain from chemotherapy for at least 3 months.
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I've finished chemo with taxanes or platinums and my cancer isn't actively getting worse.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have nerve damage not caused by platinum or taxane chemotherapy.
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I have never received TTX treatment before.
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I have not taken drugs known to affect nerve function in the last 3 months.
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I have not used opioids in the last 14 days and do not plan to use them during the study.
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My kidney function is reduced with a GFR less than 50 mL/min.
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My organ function tests are not within normal ranges.
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I have difficulty emptying my bladder completely.
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My cancer has spread to my bones.
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I have not had Botulinum toxin injections in the last 3 months and do not plan to during the study.
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I need medication regularly to prevent vomiting.
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I am currently taking antidepressants, anticonvulsants, or MAO inhibitors.
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I have been diagnosed with Major Depressive Disorder.
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I have severe asthma or breathing problems that require oxygen therapy.
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I have a heart condition affecting my heart's rhythm noted on an ECG.
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I have muscle or nerve problems in my neck or throat.
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I am not pregnant or breastfeeding.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
NPRS Pain reduction - at week 4
Secondary study objectives
NPRS Pain reduction - at week 12
NPRS Pain reduction - at week 8
Other study objectives
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had stable nerve pain for at least 14 days.I am fully active or can carry out light work.I am 21 years old or older.I can fill out the study questionnaires by myself in English or my local language.I need medication regularly to prevent vomiting.You have a high score on a pain questionnaire at the screening.I have nerve pain from chemotherapy for at least 3 months.You are not expected to live for more than 8 months.You need to have completed at least 10 out of 14 scheduled assessments before starting the trial.I am scheduled for chemotherapy or radiotherapy between my screening and the trial's end at week 13.I am currently taking antidepressants, anticonvulsants, or MAO inhibitors.My organ function tests are not within normal ranges.My kidney function is reduced with a GFR less than 50 mL/min.I am not pregnant or breastfeeding.I have nerve pain from chemotherapy for at least 3 months.You have not had sexual intercourse since your last period.I have never received TTX treatment before.My cancer has spread to my bones.I am using or willing to use birth control and have a negative pregnancy test.I have nerve damage not caused by platinum or taxane chemotherapy.I haven't started any new treatment for nerve pain in the last 60 days.I have recovered from chemotherapy side effects, except for mild nerve pain.You have a history of drinking too much alcohol, like binge drinking, within the past year, or you drink more than 3 units of alcohol every day.You have a history of drug dependency or have tested positive for drugs in your urine.I have not taken drugs known to affect nerve function in the last 3 months.I haven't taken lidocaine or similar heart rhythm drugs in the last 30 days.I have not used opioids in the last 14 days and do not plan to use them during the study.I've been on a stable dose of medication that affects my heart's rhythm for 60 days.I have difficulty emptying my bladder completely.I have not had Botulinum toxin injections in the last 3 months and do not plan to during the study.I have been diagnosed with Major Depressive Disorder.I have a heart condition affecting my heart's rhythm noted on an ECG.I have severe asthma or breathing problems that require oxygen therapy.I have muscle or nerve problems in my neck or throat.I have nerve pain from chemotherapy for at least 3 months.I've finished chemo with taxanes or platinums and my cancer isn't actively getting worse.You have a score of 4 or higher on a pain questionnaire at the screening.I have nerve pain from chemotherapy 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 currently have an intrauterine device (IUD).You have severe neuropathic pain, scoring 4 or higher on a specific questionnaire.
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.
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