Tetrodotoxin Open-label Efficacy and Safety Continuation Study (TEC-006OL)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicentre, Open-label, Long-term Efficacy and Safety Continuation Study of Subcutaneous Tetrodotoxin (TTX) for Moderate to Severe Cancer-related Pain|
- 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 [ Time Frame: Repeat treatment for patients with meaningful analgesic response ] [ Designated as safety issue: Yes ]
- For each Treatment Cycle: the total number of days a subject meets the definition of pain response. [ Time Frame: Repeat treatment for subjects with meaningful analgesic response ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||July 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
There is only one arm; active treatment with TTX
30 µg twice daily for 4 days; repeated every two weeks as long as there is a meaningful analgesic response
Other Name: TTX
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726011
|Canada, British Columbia|
|WEX Pharmaceuticals Inc.|
|Vancouver, British Columbia, Canada, V6C 1G8|
|Study Chair:||Dr. Neil Hagen, MD, FRCPC||Tom Baker Cancer Centre|