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NCT01655823 · ClinicalTrials.gov registry record · Phase 2
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, sponsored by Wex Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
NCT01655823: Clinical Trial Phase 2 study, sponsored by Wex Pharmaceuticals.
NCT01655823 is a Phase 2 study that was terminated before completion, run by Wex Pharmaceuticals. The registered enrollment target is 125 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01655823, a Phase 2 study, was terminated before completion, sponsored by Wex Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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).
Interventions
- DRUG Placebo
- DRUG Tetrodotoxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-02-11 |
| Phase | Phase 2 |
Why NCT01655823 stopped before completion
NCT01655823 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01655823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01655823 about?
NCT01655823 is a clinical study titled "The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment". 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...
What is the current status of trial NCT01655823?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2012-07. Estimated completion is 2015-02-11.
What interventions are being tested in trial NCT01655823?
The interventions under investigation include: Placebo (DRUG), Tetrodotoxin (DRUG).
Who is sponsoring clinical trial NCT01655823?
This trial is sponsored by Wex Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01655823's enrollment target sits among peer trials
125 558th of 2000 higher than 1,437 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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