The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment (TTX-CINP-201)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Wex Pharmaceuticals Inc.
Sponsor:
Information provided by (Responsible Party):
Wex Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01655823
First received: July 19, 2012
Last updated: July 7, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Pain
Peripheral Neuropathy
Neuropathic Pain
Drug: Placebo
Drug: Tetrodotoxin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Dose-Finding, Placebo Controlled, Phase II Multicenter Study of Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by Wex Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Change from Baseline in patient reported outcome for pain at Day 22 to Day 28. [ Time Frame: Day 22 to Day 28 ] [ Designated as safety issue: No ]
    To identify up to two doses/regimens of Tetrodoxin (TTX) to bring forward to Part II for further evaluation.


Secondary Outcome Measures:
  • Safety [ Time Frame: screening to Day 28 ] [ Designated as safety issue: Yes ]
    To evaluate the number and severity of Adverse Events from subjects within each cohort against the other cohorts.


Estimated Enrollment: 275
Study Start Date: July 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo (twice daily)
Placebo for injection (1 ml volume), twice a day for four consecutive days.
Drug: Placebo
Sham treatment acting as control arm
Experimental: Low dose Tetrodotoxin (twice daily)
Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Drug: Tetrodotoxin
Comparison of different dosages of Tetrodotoxin
Experimental: Mid-range dose of Tetrodotoxin (twice daily)
Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Drug: Tetrodotoxin
Comparison of different dosages of Tetrodotoxin
Experimental: Max dose Tetrodotoxin (once daily)
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.
Drug: Placebo
Sham treatment acting as control arm
Drug: Tetrodotoxin
Comparison of different dosages of Tetrodotoxin
Experimental: Max dose Tetrodotoxin (twice daily)
Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Drug: Tetrodotoxin
Comparison of different dosages of Tetrodotoxin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Females who are pregnant or nursing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655823

Contacts
Contact: Mehran Kavoosi, B.Sc. 604-676-7900 mehrank@wexpharma.com
Contact: LeaAnn Longueira, RN 302-358-2583 LeaAnn.Longueira@premier-research.com

  Show 24 Study Locations
Sponsors and Collaborators
Wex Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Wex Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01655823     History of Changes
Other Study ID Numbers: TTX-CINP-201
Study First Received: July 19, 2012
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Wex Pharmaceuticals Inc.:
Pain
Puffer fish
Tetrodotoxin
TTX
Neuropathy
Chemotherapy
WEX Pharmaceuticals

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuralgia
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Tetrodotoxin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014