Clareo Health | The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Wex Pharmaceuticals Inc.
With
Premier Research
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
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.
