PainPhase 2TTX-CINP-201NCT01655823
The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment
A Phase 2 study testing Tetrodotoxin in people with Pain and Peripheral Neuropathy, run by Wex Pharmaceuticals Inc. at 23 sites in United States.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of many chemotherapeutic agents including vincristine, paclitaxel, cisplatin, oxaliplatin, bortezomib and ixabepilone. Chemotherapy-induced peripheral neuropathy commonly occurs in greater than 40% of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Peripheral Neuropathy, Neuropathic Pain
- 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
- 125 participants
- Where
- 23 sitesUnited States
- Study dates
- Jul 2012to 11 Feb 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- If female, not of childbearing potential.
- Patients with documented neuropathic pain
- Cancer Patients who have completed a chemotherapy regimen which included taxanes or platinums (or both) and have no evidence actively progressive disease. Concurrent hormonal therapies are allowed
- Patients with stable moderate to severe neuropathic pain
- Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Patients who are able to complete the study-related questionnaires independently in either English or Spanish.
Who cannot join
- History of peripheral neuropathy attributed to any cause other than chemotherapy.
- Patients receiving any concurrent agents known to cause peripheral neuropathy within 30 days of Randomization.
- Current use of other therapy (ies), including "alternative" therapies, for treatment of peripheral neuropathy within 30 days of Randomization (with the exception of protocol allowed concurrent medications).
- Patients who used controlled release opioids within seven days of baseline period or who expect to use controlled release opioids at any time from baseline to end of study.
- Patients with abnormal kidney function.
- Patients with bone metastases.
Show all 15Show fewer
- Patients scheduled for treatment for their cancer with chemotherapy or radiotherapy between screening and the end of study visit.
- Current use of lidocaine and other types of antiarrhythmic drugs within 30 days of Randomization.
- Current use of scopolamine and acetylcholinesterase-inhibiting drugs such as physostigmine within 30 days of Randomization.
- Current cause of Chemotherapy Induced Neuropathic Pain attributed to Velcade (Bortezomib) or vinca alkaloids or analogues such as vincristine, vinblasine, vinorelbine and vindesine.
- Current use of tricyclic antidepressant medication, anticonvulsants and monoamine oxidase inhibitors.
- Patients with current uncontrolled asthma or lung disease.
- Patients with significant heart disease.
- Use of an investigational agent within 30 days prior to screening or is scheduled to receive an investigational drug other than TTX during the course of the study.
- Females who are pregnant or nursing
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87103
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
St. Vincent's Medical Center
Bridgeport, Connecticut, 06606
St. Louis Cancer Care
Bridgeton, Missouri, 63044
University of Texas Southwestern
Dallas, Texas, 75390-9179
Cancer Center of Middle Georgia
Dublin, Georgia, 31021
Lalita Pandit
Fountain Valley, California, 92708
Robert Moss
Fountain Valley, California, 92708
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Alliance Research Centers
Laguna Hills, California, 92653
Global Research Management
Los Angeles, California, 90027
Innovative Clinical Research
Los Angeles, California, 90603
Signal Point Clinical Research Center
Middletown, Ohio, 45042
El Camino Cancer Center
Mountain View, California, 94040
Institute of Pain Research
Oklahoma City, Oklahoma, 73104
Medsol Clinical Research Center
Port Charlotte, Florida, 33952
Pacific Cancer Care
Salinas, California, 93901
Jean Brown Research
Salt Lake City, Utah, 84124
Redwood Regional Medical Group
Santa Rosa, California, 95403
Mercy Medical Research Institute
Springfield, Missouri, 65807
Axcess Medical Research
Wellington, Florida, 33414
Cancer Center of Kansas
Wichita, Kansas, 67214
About this study
Official title: A Randomized, Double-Blind, Dose-Finding, Placebo Controlled, Phase II Multicenter Study of Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of many chemotherapeutic agents including vincristine, paclitaxel, cisplatin, oxaliplatin, bortezomib and ixabepilone. Chemotherapy-induced peripheral neuropathy commonly occurs in greater than 40% of patients. To improve the peripheral neuropathy, the chemotherapy dosing is often either decreased or discontinued potentially affecting tumor responsiveness, prognosis, and survival.
There is an unmet medical need for treatment of cancer patients with chemotherapy induced neuropathic pain (CINP) and the proposed study will investigate the efficacy and safety of multiple dose levels of tetrodotoxin (TTX) versus placebo in moderate to severe neuropathic pain caused by chemotherapy.
- Conditions
- Pain, Peripheral Neuropathy, Neuropathic Pain
- Being tested
- Placebo, Tetrodotoxin
- Keywords
- Pain, Puffer fish, Tetrodotoxin, TTX, Neuropathy, Chemotherapy, WEX Pharmaceuticals
- Medical subject headings
- Pain, Peripheral Nervous System Diseases, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called placebo for injection
Sham treatment acting as control arm
TetrodotoxinDrug
Also called TTX for injection
Comparison of different dosages of Tetrodotoxin
| Study group | Role | What they receive |
|---|---|---|
| Placebo (twice daily) | Placebo comparator | Placebo for injection (1 ml volume), twice a day for four consecutive days. Receives: Drug: Placebo |
| Low dose Tetrodotoxin (twice daily) | Experimental | Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days. Receives: Drug: Tetrodotoxin |
| Mid-range dose of Tetrodotoxin (twice daily) | Experimental | Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days. Receives: Drug: Tetrodotoxin |
| Max dose Tetrodotoxin (once daily) | Experimental | Max dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days. Receives: Drug: Placebo; Drug: Tetrodotoxin |
| Max dose Tetrodotoxin (twice daily) | Experimental | Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days. Receives: Drug: Tetrodotoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Patient Reported Outcome for Pain at Day 22 to Day 28.
The primary efficacy endpoint for Part I was the change from baseline in weekly average NPRS scores at 22 to 28 days after treatment. Baseline was defined as the average of NPRS scores for the last 7 days prior to dosing. Pain was assessed using a Numerical Pain Rating Scale (NPRS) with a range of 0 (no pain) to 10 (extreme pain).
Measured: Day 22 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2015
- Study completion11 Feb 2015
Why it stopped: Interim analysis completed and decided to terminate and proceed to Phase 3 trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wex Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- Samuel Goldlust, MD, Principal investigator, Hackensack University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655823
- Sponsor's protocol ID
- TTX-CINP-201
- Acronym
- TTX-CINP-201
- Status last verified
- Oct 2018
- First submitted
- 19 Jul 2012
- Last updated
- 30 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Dose-Finding, Placebo Controlled, Phase II Multicenter Study of Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01655823
- Acronym / sponsor ID
- TTX-CINP-201 / TTX-CINP-201
- Conditions
- Pain, Peripheral Neuropathy, Neuropathic Pain
- Keywords
- Pain, Puffer fish, Tetrodotoxin, TTX, Neuropathy, Chemotherapy, WEX Pharmaceuticals
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis completed and decided to terminate and proceed to Phase 3 trial.
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Wex Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- Jul 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- 11 Feb 2015 (actual)
- First posted
- 2 Aug 2012 (estimated)
- Results
- Posted 30 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of many chemotherapeutic agents including vincristine, paclitaxel, cisplatin, oxaliplatin, bortezomib and ixabepilone. Chemotherapy-induced peripheral neuropathy commonly occurs in greater than 40% of patients. To improve the peripheral neuropathy, the chemotherapy dosing is often either decreased or discontinued potentially affecting tumor responsiveness, prognosis, and survival.
There is an unmet medical need for treatment of cancer patients with chemotherapy induced neuropathic pain (CINP) and the proposed study will investigate the efficacy and safety of multiple dose levels of tetrodotoxin (TTX) versus placebo in moderate to severe neuropathic pain caused by chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo (twice daily) | Placebo comparator | Drug: PlaceboPlacebo for injection (1 ml volume), twice a day for four consecutive days. |
| Low dose Tetrodotoxin (twice daily) | Experimental | Drug: TetrodotoxinLow dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days. |
| Mid-range dose of Tetrodotoxin (twice daily) | Experimental | Drug: TetrodotoxinMid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days. |
| Max dose Tetrodotoxin (once daily) | Experimental | Drug: Placebo, Drug: TetrodotoxinMax dose Tetrodotoxin injectable (1 ml volume), once a day in the morning for four consecutive days and Placebo for injection (1 ml volume), once a day in the afternoon for four consecutive days. Total of 4 treatment days. |
| Max dose Tetrodotoxin (twice daily) | Experimental | Drug: TetrodotoxinMax dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- If female, not of childbearing potential.
- Patients with documented neuropathic pain
- Cancer Patients who have completed a chemotherapy regimen which included taxanes or platinums (or both) and have no evidence actively progressive disease. Concurrent hormonal therapies are allowed
- Patients with stable moderate to severe neuropathic pain
- Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Key exclusion criteria (15 listed)
- History of peripheral neuropathy attributed to any cause other than chemotherapy.
- Patients receiving any concurrent agents known to cause peripheral neuropathy within 30 days of Randomization.
- Current use of other therapy (ies), including "alternative" therapies, for treatment of peripheral neuropathy within 30 days of Randomization (with the exception of protocol allowed concurrent medications).
- Patients who used controlled release opioids within seven days of baseline period or who expect to use controlled release opioids at any time from baseline to end of study.
- Patients with abnormal kidney function.
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 |
|---|---|---|
| PlaceboAlso: placebo for injectionSham treatment acting as control arm | Drug | Max dose Tetrodotoxin (once daily), Placebo (twice daily) |
| TetrodotoxinAlso: TTX for injectionComparison of different dosages of Tetrodotoxin | Drug | Low dose Tetrodotoxin (twice daily), Max dose Tetrodotoxin (once daily), Max dose Tetrodotoxin (twice daily), Mid-range dose of Tetrodotoxin (twice daily) |
Primary outcome
Change From Baseline in Patient Reported Outcome for Pain at Day 22 to Day 28.
Time frame: Day 22 to Day 28
The primary efficacy endpoint for Part I was the change from baseline in weekly average NPRS scores at 22 to 28 days after treatment. Baseline was defined as the average of NPRS scores for the last 7 days prior to dosing. Pain was assessed using a Numerical Pain Rating Scale (NPRS) with a range of 0 (no pain) to 10 (extreme pain).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Samuel Goldlust, MD principal investigator
Hackensack University
23 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 Pain and Peripheral Neuropathy, run by Wex Pharmaceuticals Inc. at 23 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 6 inclusion and 15 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 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
Yes. Results are posted in the registry (first posted 30 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Patient Reported Outcome for Pain at Day 22 to Day 28. (time frame: Day 22 to Day 28). 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 30 Oct 2018.