Status:
Recruiting
Disease Site:
Neuropathic
Phase:
Official Title:
TTX-CINP-202 A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Trial of Sincle Cycle Tetrodotoxin in the Treatment of Chemotherapy-Induced Neuropathic Pain
NCT ID:
NCT#05359133
Link to Full Details:
Description:
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.
Eligibility:
Male and Female – 21 years and older
Inclusion Criteria:
- Neuropathic pain attributed to platinum and/or taxane chemotherapy for a minimum of 3 months preceding screening
- No evidence of disease progression
- At least 90 days since the last dose of cytotoxic chemotherapy/radiotherapy agent
- Moderate to severe chemotherapy induced neuropathic pain that has been stable for 14 days
Exclusion Criteria:
- History of peripheral neuropathy attributable to any cause other than platinum or taxane chemotherapy
- Current use of any other therapy for the treatment of neuropathic pain within 60 days unless the dose is stable
- Current use of opioids or plans to start using opioids during the study period. However, opioids at doses less than 90mg morphine equivalents per day are permitted as long as the dose has been stable for at least 30 days
- Subjects who require rescue medication for breakthrough pain with medication other than acetaminophen or ibuprofen
- Current use of lidocaine
- Botulinum toxin (Botox) injections in the last 3 months