Tetrodotoxin Open-label Efficacy and Safety Continuation Study

NCT00726011 | Completed Phase 3

• 1 other identifier: TEC-006OL
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

Different pathophysiologic mechanisms are responsible for the development of chronic pain disorders. Pain pathways are triggered in part by ectopic discharges of voltage-sensitive sodium channels, which are in abundance in both the peripheral and the central nervous systems. Tetrodotoxin (TTX) is a selective blocker of Na+ channels and causes analgesia either by decreasing the propagation of action potentials by Na+ channels and/or by blocking of ectopic discharges associated with chronic pain. TTX is extracted from the puffer fish (fugu). Results from animal pharmacology studies revealed that TTX is a more potent analgesic than standard analgesic agents such as aspirin, morphine or meperidine. At present, the management of severe cancer pain generally includes the use of opiates. This can often result in undesirable side effects, and treatment with this type of medication is not always effective. Because currently available pain-relieving therapy is unsatisfactory for many patients, there is a need for new therapeutic approaches for the management of moderate or severe cancer pain. Recent studies indicate that intramuscular (into a muscle) or subcutaneous (under the skin) injections of tetrodotoxin (TTX) may reduce pain in cancer patients who did not respond to standard therapies. The current proposed study (TEC-006OL) is designed to provide the option for all patients who participated in the TEC-006 study (both tetrodotoxin and placebo-treated) to receive or continue to receive tetrodotoxin treatment.

Conditions

Pain; Cancer

Keywords

due; cancer treatment

Outcome Measures

Primary Outcomes (1)

• Efficacy: long-term efficacy of tetrodotoxin (TTX) in reducing pain and improving quality of life. Safety: long-term safety and tolerability of s.c. TTX

  Repeat treatment for patients with meaningful analgesic response

Secondary Outcomes (1)

• For each Treatment Cycle: the total number of days a subject meets the definition of pain response.

  Repeat treatment for subjects with meaningful analgesic response

Study Arms (1)

Tetrodotoxin

EXPERIMENTAL

There is only one arm; active treatment with TTX

Biological: Tetrodotoxin

Interventions

Tetrodotoxin BIOLOGICAL

30 µg twice daily for 4 days; repeated every two weeks as long as there is a meaningful analgesic response

Also known as: TTX

Tetrodotoxin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• NOTE: The blinded treatment assignment of patients in the TEC-006 will not be revealed to either the investigator or the patient. Patients will not be aware which treatment they received in the TEC-006 study. All patients will receive tetrodotoxin treatment in the TEC-006OL study.
• Male or female 18 years of age and over
• In-patients or out-patients with a diagnosis of cancer
• Patients must be experiencing somatic, visceral and/or neuropathic pain related to cancer.
• Compliant to the requirements of the TEC-006 Protocol.
• Inadequately controlled pain: Pain intensity described as 'moderate', 'severe' or 'excruciating', as assessed by the VRS during the screening/baseline period of the First Treatment Cycle, and a baseline pain intensity score of ≥4 as assessed by NRS (worst, average, or component-specific pain).
• Meet the Responder or Clinical Responder definition for repeat cycle treatment (cycle #2 to cycle #4)
• Life expectancy of \> 3 months.
• Ability to communicate well with the Investigator and to comply with the requirements of the entire study.
• \. Willingness to give written informed consent (prior to any study-related procedures being performed) and to be able to adhere to the study restrictions, appointments and examination schedule.
• Planned initiation of chemotherapy, radiotherapy or bisphosphonates within 30 days prior to enrolment.
• Known renal disease.
• If it has been more than 14 days since their TEC\_006 End of Study Visit or their pain returned to baseline since their last tetrodotoxin treatment cycle (for repeat cycle).
• Patient has previously completed 4 cycles of tetrodotoxin
• If it has been more than 6 months since patient signed consent to participate in the TEC-006 OL study.

Sponsors & Collaborators

• Wex Pharmaceuticals Inc.: lead

Study Sites (1)

WEX Pharmaceuticals Inc.

Vancouver, British Columbia, V6C 1G8, Canada

Location

MeSH Terms

Conditions

Pain; Neoplasms

Interventions

Tetrodotoxin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Marine Toxins; Toxins, Biological; Biological Factors

Study Officials

• Dr. Neil Hagen, MD, FRCPC

  Tom Baker Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 31, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: July 1, 2012
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

CA (1)