A Multicentre, Open-label, Long-term Efficacy and Safety Continuation Study of Subcutaneous Tetrodotoxin (TTX) for Moderate to Severe Cancer-related Pain
Study Objectives: In cancer patients with moderate to severe pain who participated in the
- To assess the long-term efficacy of subcutaneous tetrodotoxin (TTX) treatment in
reducing the pain outcome and improving the quality of life (physical and emotional
- To assess the long-term safety and tolerability of subcutaneous tetrodotoxin (TTX).
• To assess the duration of analgesia following repeated cycles of tetrodotoxin (TTX)
Overall Study Design:
This will be a multicentre, open-label, continuation trial of the efficacy and safety of
tetrodotoxin in patients with inadequately controlled moderate to severe pain associated
with cancer. All patients who participated in the TEC-006 study (tetrodotoxin and
placebo-treated), who would like to continue with tetrodotoxin treatment and meet the
inclusion/exclusion criteria, are eligible to receive the First Treatment Cycle for this
The study will be conducted at all centres participating in the TEC-006 study. Patients may
receive repeated cycles of treatment with tetrodotoxin. Each Treatment Cycle will consist of
4 days of treatment with 30 μg b.i.d. of tetrodotoxin injected subcutaneously. Each
Treatment Cycle will last from the start of treatment to the end of the analgesic response.
All patients completing the first Treatment Cycle in this protocol must meet the criteria of
the Responder (First TEC-006OL Treatment Cycle) definition in order to be eligible for a
second Treatment Cycle. Patient eligibility for all subsequent Treatment Cycles will be
determined using the eligibility criteria for a Repeated Treatment Cycle.
Up to 120 patients.
30ug TTX(Tetrodotoxin injectable) injected subcutaneously twice daily for 4 days.
Worst pain in last 24 hours, average pain in last 24 hours, and/or component-specific pain
intensity in last 24 hours, ATC and breakthrough analgesic use, impact of pain on physical
functioning (general activity, walking ability, or normal work), and emotional functioning
(mood, relations with other people, or enjoyment of life).
Safety assessments will include adverse event reporting, vitals signs, physical and
neurological examinations, 12-lead electrocardiogram, clinical laboratory tests.
Data Analysis Method:
An initial analysis of results of the TEC-006OL study will be completed in parallel with the
TEC-006 study. Further periodic analyses will be completed every 6 months until the study is
All efficacy and safety analyses will be performed for subjects that are dosed at least once
in protocol TEC-006OL. All analyses performed will be descriptive. No statistics involving
hypothesis testing will be performed.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Dr. Neil Hagen, MD, FRCPC
Tom Baker Cancer Centre
Canada: Health Canada