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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)

Primary Purpose

Pain, Peripheral Neuropathy, Neuropathic Pain

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Tetrodotoxin
Sponsored by
Wex Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Puffer fish, Tetrodotoxin, TTX, Neuropathy, Chemotherapy, WEX Pharmaceuticals

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lalita Pandit
  • Robert Moss
  • Alliance Research Centers
  • Global Research Management
  • Innovative Clinical Research
  • El Camino Cancer Center
  • Pacific Cancer Care
  • Redwood Regional Medical Group
  • St. Vincent's Medical Center
  • Medsol Clinical Research Center
  • Axcess Medical Research
  • Cancer Center of Middle Georgia
  • Cancer Center of Kansas
  • Center for Cancer and Blood Disorders
  • St. Louis Cancer Care
  • Mercy Medical Research Institute
  • John Theurer Cancer Center at Hackensack University Medical Center
  • New Mexico Oncology Hematology Consultants
  • Signal Point Clinical Research Center
  • Institute of Pain Research
  • Gettysburg Cancer Center
  • University of Texas Southwestern
  • Jean Brown Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo (twice daily)

Low dose Tetrodotoxin (twice daily)

Mid-range dose of Tetrodotoxin (twice daily)

Max dose Tetrodotoxin (once daily)

Max dose Tetrodotoxin (twice daily)

Arm Description

Placebo for injection (1 ml volume), twice a day for four consecutive days.

Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.

Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.

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.

Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
July 19, 2012
Last Updated
October 5, 2018
Sponsor
Wex Pharmaceuticals Inc.
Collaborators
Premier Research Group plc
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1. Study Identification

Unique Protocol Identification Number
NCT01655823
Brief Title
The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment
Acronym
TTX-CINP-201
Official Title
A Randomized, Double-Blind, Dose-Finding, Placebo Controlled, Phase II Multicenter Study of Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis completed and decided to terminate and proceed to Phase 3 trial.
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 11, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wex Pharmaceuticals Inc.
Collaborators
Premier Research Group plc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Peripheral Neuropathy, Neuropathic Pain
Keywords
Pain, Puffer fish, Tetrodotoxin, TTX, Neuropathy, Chemotherapy, WEX Pharmaceuticals

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (twice daily)
Arm Type
Placebo Comparator
Arm Description
Placebo for injection (1 ml volume), twice a day for four consecutive days.
Arm Title
Low dose Tetrodotoxin (twice daily)
Arm Type
Experimental
Arm Description
Low dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Arm Title
Mid-range dose of Tetrodotoxin (twice daily)
Arm Type
Experimental
Arm Description
Mid-range dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Arm Title
Max dose Tetrodotoxin (once daily)
Arm Type
Experimental
Arm Description
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.
Arm Title
Max dose Tetrodotoxin (twice daily)
Arm Type
Experimental
Arm Description
Max dose Tetrodotoxin injectable (1 ml volume), twice a day for four consecutive days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo for injection
Intervention Description
Sham treatment acting as control arm
Intervention Type
Drug
Intervention Name(s)
Tetrodotoxin
Other Intervention Name(s)
TTX for injection
Intervention Description
Comparison of different dosages of Tetrodotoxin
Primary Outcome Measure Information:
Title
Change From Baseline in Patient Reported Outcome for Pain at Day 22 to Day 28.
Description
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).
Time Frame
Day 22 to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Goldlust, MD
Organizational Affiliation
Hackensack University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lalita Pandit
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Robert Moss
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Alliance Research Centers
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Global Research Management
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Innovative Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
El Camino Cancer Center
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Pacific Cancer Care
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
Redwood Regional Medical Group
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
St. Vincent's Medical Center
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Medsol Clinical Research Center
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Axcess Medical Research
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Cancer Center of Middle Georgia
City
Dublin
State/Province
Georgia
ZIP/Postal Code
31021
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
St. Louis Cancer Care
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Mercy Medical Research Institute
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
New Mexico Oncology Hematology Consultants
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87103
Country
United States
Facility Name
Signal Point Clinical Research Center
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Institute of Pain Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Gettysburg Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9179
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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