Chemotherapy-induced Neuropathic PainPhase 2NCT05359133
A Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Trial of Single Cycle Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
A Phase 2 study testing Tetrodotoxin in people with Chemotherapy-induced Neuropathic Pain and Chemotherapy-induced Peripheral Neuropathy, run by Wex Pharmaceuticals Inc. at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chemotherapy-induced Neuropathic Pain, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Tetrodotoxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 15 sitesUnited States
- Study dates
- 19 Apr 2022to 14 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥21 years.
- Subjects and their partners must agree to using effective methods of birth control from the time of signature of the informed consent form up until 30 days following the end of the Treatment Period.
- Subjects with neuropathic pain attributed to platinum and/or taxane chemotherapy for a minimum of 3 months duration from screening.
- Subjects with cancer who have completed a chemotherapy regimen that included taxanes or platinums (or in combination) and have no clinical evidence of actively progressive disease. Subjects must have undergone at least a 90-Day washout period between the last dose of cytotoxic chemotherapy/radiotherapy agent and randomization. Concurrent hormonal therapy and immunotherapy that do not cause neuropathy are permitted.
- Subjects with a score of 4 or higher out of 10 on the Diagnosing Neuropathic Pain-DN4 Questionnaire (Appendix F) at Screening.
- Subjects must have at least 10 non-missing scores in the 14 Days prior to randomization during their Baseline Period.
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- Subjects with moderate to severe neuropathic pain that has been stable for 14 Days. Stable pain will be confirmed using an 11-point (0-10) NPRS. To establish moderate or severe stable pain, the average daily pain scores during the 14-Day Baseline Period must be ≥4 with fluctuation in the daily pain score of ≤2 points in increase or decrease. Subjects with an average pain score >9 at Baseline will be excluded.
- Subjects with an Eastern Cooperative Oncology Group Performance Status score of 0 or 1 (Oken et al, 1982).
- Subjects who are able to communicate well with the trial staff and to comply with the trial requirements (restrictions, appointments, and examination schedule).
- Subjects who are able to complete the trial-related questionnaires independently in either English or in the local language.
- Subjects who sign an informed consent document (prior to the performance of any trial related procedures).
Who cannot join
- History of peripheral neuropathy attributed to any cause other than platinum or taxane chemotherapy (e.g., radiotherapy, vinca alkaloids, diabetes, alcohol, toxin, hereditary, human immunodeficiency virus, or severe malnutrition).
- Subjects who have received TTX at any time prior to enrolment.
- Subjects receiving agents known to cause peripheral neuropathy within 90 Days of randomization.
- Current use of any other therapy (including alternative nonmedical therapy) for the treatment of neuropathic pain within 60 Days of randomization unless the dose is stable for the 60 Days immediately prior to randomization. Subjects who fail this criterion can be rescreened after 60 Days of stability.
- Current use of opioids or plans to start using opioids during the study period. However, opioids at doses of ≤90 mg morphine equivalents per day are permitted as long as subject is on stable dose for at least 60 days prior to randomization and plan on staying on that stable dose (fixed dose and schedule) throughout the study.
- Subjects who require rescue medication for breakthrough pain with medication other than acetaminophen or Ibuprofen. Before and after randomization, acetaminophen will be allowed at doses up to 2600 mg per day <3 times a week or Ibuprofen will be allowed at doses up to 1200 mg per day <3 times a week.
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- Any concomitant medication that prolongs the QT or QRS interval unless on a stable dose for 60 Days prior to randomization.
- Subjects with known impaired renal function as determined by a screening serum creatinine >1.5x normal.
- Subjects who have not recovered from all toxicities related to chemotherapy to < grade 1 or mild AE's with the exception of CINP.
- Subjects who have inadequate organ function tests including: Hgb < 10 g/dl; ANC < 1500/µL; Plt. count < 100,000/µL; liver function (ALT and/or AST) more than 2 times the upper limit of normal.
- Subjects with urinary retention.
- Subjects with documented bone metastases at the time of trial entry.
- Subjects with predicted life expectancy of <8 months.
- Subjects scheduled for chemotherapy or radiotherapy between Screening and the End of Trial visit (Week 13).
- Current use of lidocaine (including Lidoderm) and other types of sodium channel antiarrhythmic drugs within 30 Days of randomization.
- Subjects who have been injected with Botulinum toxin (e.g., Botox®) in the 3 months prior to randomization, or who plan to receive a Botulinum toxin injection during the study period.
- Subjects who require regular antiemetic medication.
- Current use of tricyclic antidepressant medication, anticonvulsants, or monoamine oxidase inhibitors. Stable use of those medications for at least 2 months is permissible if the subject has qualifying pain and plans to remain on a stable dose throughout the trial.
- Subjects will be excluded if they have a current diagnosis of uncontrolled Major Depressive Disorder.
- Subjects with current uncontrolled asthma, carbon dioxide retention, or oxygen saturation <92% on room air, or require oxygen therapy at any concentration.
- Subjects with second- or third-degree heart block or prolonged QTc interval (corrected for rate) on screening electrocardiogram (ECG) (i.e., confirmed >450 msec for men and >470 msec for women on repeated occasion) or any other active cardiac arrhythmia or abnormality that might constitute a clinical risk.
- Subjects with neuromuscular conditions, including but not limited to any impairment that influence swallowing or breathing function.
- Use of an investigational agent within 30 Days prior to Screening or scheduled to receive an investigational drug other than TTX during the course of the trial.
- History of alcoholism, or current intake deemed excessive by the investigator or routine use averaging >3 units of alcohol per day.
- Active substance abuse or drug dependency in the opinion of the investigator, including prescription drug abuse.
- Women who are pregnant or breast feeding.
- Any other condition that in the opinion of the investigators is likely to interfere with treatment, impede data collection, or that poses a risk to the subject.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Paradigm Clinical Research
Boise, Idaho, 83709
Oncology Specialists of Charlotte
Charlotte, North Carolina, 28207
Care Access Research
Clifton, New Jersey, 07013
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
ES Clinical Research Group
Garden City, New York, 11530
Center for Oncology and Blood Disorders (COBD)
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
St Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Clinical Trials of SWLA
Lake Charles, Louisiana, 70601
Care Access Research
Macon, Georgia, 31201
MEDSOL Clinical Research Center
Port Charlotte, Florida, 33952
Syrentis Clinical Research
Santa Ana, California, 92705
Providence Medical Foundation
Santa Rosa, California, 95403
SUNY Upstate Medical University
Syracuse, New York, 13210
Oklahoma Cancer Specialists and Research Institute (OCSRI)
Tulsa, Oklahoma, 74146
About this study
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), randomization and a 4-day treatment period, 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.
- Being tested
- Tetrodotoxin, Placebo
- Keywords
- CINP, Chemotherapy-induced Neuropathic Pain, Pain, Neuropathy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetrodotoxinDrug
Also called Halneuron
TTX for Injection, 30 µg/mL, is a sterile, nonpyrogenic, white, lyophilized powder provided in a 5 mL glass single-use vial with a rubber stopper and aluminum overseal. Upon reconstitution of the lyophilized product with 1.1 mL of sterile water for injection, each vial delivers 1 mL of fluid containing 30 µg of TTX with a pH of 4.0 to 5.5
PlaceboDrug
Also called Sterile 0.9% sodium chloride injection
Placebo for injection is a sterile 0.9% sodium chloride injection or normal saline for injection. To ensure blinding, subjects receiving placebo will receive the same volume (1.0 mL) for injection to match the volume used for the cohorts assigned to receive active trial drug.
Route and frequency: 1.0 mL of placebo, SC injection in the thigh or abdomen, twice daily for 4 Days in each treatment Cycle.
| Study group | Role | What they receive |
|---|---|---|
| Tetrodotoxin for injection | Active comparator | 30 µg, 1 ml SC injection in the thigh or abdomen, twice daily for 4 Days Receives: Drug: Tetrodotoxin |
| Placebo | Placebo comparator | 1.0 mL of placebo, SC injection in the thigh or abdomen, twice daily for 4 Days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS Pain reduction - at week 4
The Change from Baseline (average of Days -14 to -1) at Week 4 in average weekly NPRS scores in subjects treated with TTX compared to Placebo
Measured: At week 4
Secondary outcomes (2)
NPRS Pain reduction - at week 8
The Change from Baseline (average of Days -14 to -1) at Week 8 in average weekly NPRS scores in subjects treated with TTX compared to Placebo
Measured: At week 8
NPRS Pain reduction - at week 12
The Change from Baseline (average of Days -14 to -1) at Week 12 in average weekly NPRS scores in subjects treated with TTX compared to Placebo
Measured: At week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start19 Apr 2022
- Primary completion14 Oct 2024
- Study completion14 Oct 2024
Why it stopped: Study was terminated due to lack of funding to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wex Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Walter Korz, Study director, COO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359133
- Sponsor's protocol ID
- TTX-CINP-202
- Status last verified
- Aug 2024
- First submitted
- 25 Apr 2022
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Trial of Single Cycle Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
- ClinicalTrials.gov ID
- NCT05359133
- Acronym / sponsor ID
- TTX-CINP-202
- Keywords
- CINP, Chemotherapy-induced Neuropathic Pain, Pain, Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to lack of funding to continue the study.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Wex Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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), randomization and a 4-day treatment period, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetrodotoxin for injection | Active comparator | Drug: Tetrodotoxin30 µg, 1 ml SC injection in the thigh or abdomen, twice daily for 4 Days |
| Placebo | Placebo comparator | Drug: Placebo1.0 mL of placebo, SC injection in the thigh or abdomen, twice daily for 4 Days |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects aged ≥21 years.
- Subjects and their partners must agree to using effective methods of birth control from the time of signature of the informed consent form up until 30 days following the end of the Treatment Period.
- Subjects with neuropathic pain attributed to platinum and/or taxane chemotherapy for a minimum of 3 months duration from screening.
- Subjects with cancer who have completed a chemotherapy regimen that included taxanes or platinums (or in combination) and have no clinical evidence of actively progressive disease. Subjects must have undergone at least a 90-Day washout period between the last dose of cytotoxic chemotherapy/radiotherapy agent and randomization. Concurrent hormonal therapy and immunotherapy that do not cause neuropathy are permitted.
- Subjects with a score of 4 or higher out of 10 on the Diagnosing Neuropathic Pain-DN4 Questionnaire (Appendix F) at Screening.
Key exclusion criteria (27 listed)
- History of peripheral neuropathy attributed to any cause other than platinum or taxane chemotherapy (e.g., radiotherapy, vinca alkaloids, diabetes, alcohol, toxin, hereditary, human immunodeficiency virus, or severe malnutrition).
- Subjects who have received TTX at any time prior to enrolment.
- Subjects receiving agents known to cause peripheral neuropathy within 90 Days of randomization.
- Current use of any other therapy (including alternative nonmedical therapy) for the treatment of neuropathic pain within 60 Days of randomization unless the dose is stable for the 60 Days immediately prior to randomization. Subjects who fail this criterion can be rescreened after 60 Days of stability.
- Current use of opioids or plans to start using opioids during the study period. However, opioids at doses of ≤90 mg morphine equivalents per day are permitted as long as subject is on stable dose for at least 60 days prior to randomization and plan on staying on that stable dose (fixed dose and schedule) throughout the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetrodotoxinAlso: HalneuronTTX for Injection, 30 µg/mL, is a sterile, nonpyrogenic, white, lyophilized powder provided in a 5 mL glass single-use vial with a rubber stopper and aluminum overseal. Upon reconstitution of the lyophilized product with 1.1 mL of sterile water for injection, each vial delivers 1 mL of fluid containing 30 µg of TTX with a pH of 4.0 to 5.5 | Drug | Tetrodotoxin for injection |
| PlaceboAlso: Sterile 0.9% sodium chloride injectionPlacebo for injection is a sterile 0.9% sodium chloride injection or normal saline for injection. To ensure blinding, subjects receiving placebo will receive the same volume (1.0 mL) for injection to match the volume used for the cohorts assigned to receive active trial drug. Route and frequency: 1.0 mL of placebo, SC injection in the thigh or abdomen, twice daily for 4 Days in each treatment Cycle. | Drug | Placebo |
Primary outcome
NPRS Pain reduction - at week 4
Time frame: At week 4
The Change from Baseline (average of Days -14 to -1) at Week 4 in average weekly NPRS scores in subjects treated with TTX compared to Placebo
2 secondary outcomes
NPRS Pain reduction - at week 8
Time frame: At week 8
NPRS Pain reduction - at week 12
Time frame: At week 12
Results and safety
The study was stopped early (reason given: Study was terminated due to lack of funding to continue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Korz study director
COO
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tetrodotoxin in people with Chemotherapy-induced Neuropathic Pain and Chemotherapy-induced Peripheral Neuropathy, run by Wex Pharmaceuticals Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was terminated due to lack of funding to continue the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS Pain reduction - at week 4 (time frame: At week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.