PainPhase 3TEC-006OLNCT00726011
Tetrodotoxin Open-label Efficacy and Safety Continuation Study
A Phase 3 study testing Tetrodotoxin in people with Pain and Cancer, run by Wex Pharmaceuticals Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Tetrodotoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who participated in the TEC-006 study (tetrodotoxin and placebo-treated) will be eligible for inclusion in this study provided they wish to continue to receive treatment and meet the inclusion and exclusion criteria.
- 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.
- A patient will be eligible or continue to be eligible for inclusion in this study (First Treatment Cycle and subsequent Treatment Cycles) only if all of the following criteria apply:
- 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.
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- 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.
- 8. 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.
Who cannot join
- A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- 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.
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- Use of anaesthetics.
- Use of lidocaine, and other types of antiarrhythmic drugs.
- Use of scopolamine and acetylcholinesterase-inhibiting drugs such as physostigmine.
- History of CO2 retention, or SaO2 <80% either on room air or O2 of not greater than 2-4 L/min by nasal cannula.
- Second or third degree heart block or prolonged QTc interval (corrected for rate) on screening ECG (confirmed > 450 msec on repeated occasion) or any other active cardiac arrhythmia or abnormality that would constitute a clinical risk.
- Coagulation or bleeding defects if in the opinion of the Investigator this represents a risk to the subject considering the subcutaneous (s.c.) route of administration.
- Known hypersensitivity to puffer fish, tetrodotoxin and/or its derivatives.
- Received an investigational agent other than tetrodotoxin within 30 days prior to screening or who is scheduled to receive an investigational drug other than tetrodotoxin during the course of the study.
- Females who are lactating or at risk of pregnancy (i.e., sexually active with fertile males and not using an adequate form of birth control).
- Females with a positive pregnancy test at screening or on admission to study site.
- Any other condition that, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study or poses a risk to the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre, Open-label, Long-term Efficacy and Safety Continuation Study of Subcutaneous Tetrodotoxin (TTX) for Moderate to Severe Cancer-related Pain
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.
Read more
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.
Read the detailed description
Study Objectives: In cancer patients with moderate to severe pain who participated in the TEC-006 study:
Primary Objectives:
- 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 functioning).
- To assess the long-term safety and tolerability of subcutaneous tetrodotoxin (TTX).
Secondary Objective:
- To assess the duration of analgesia following repeated cycles of tetrodotoxin (TTX) treatment.
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 continuation study.
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.
Sample Size:
Up to 120 patients.
Investigational Product:
30ug TTX(Tetrodotoxin injectable) injected subcutaneously twice daily for 4 days.
Efficacy Variables:
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 Variables:
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 closed.
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.
- Being tested
- Tetrodotoxin
- Keywords
- due, cancer treatment
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetrodotoxinBiological
Also called TTX
30 µg twice daily for 4 days; repeated every two weeks as long as there is a meaningful analgesic response
| Study group | Role | What they receive |
|---|---|---|
| Tetrodotoxin | Experimental | There is only one arm; active treatment with TTX Receives: Biological: Tetrodotoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Repeat treatment for subjects with meaningful analgesic response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wex Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Neil Hagen, MD, FRCPC, Study chair, Tom Baker Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726011
- Sponsor's protocol ID
- TEC-006OL
- Acronym
- TEC-006OL
- Status last verified
- Oct 2012
- First submitted
- 28 Jul 2008
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label, Long-term Efficacy and Safety Continuation Study of Subcutaneous Tetrodotoxin (TTX) for Moderate to Severe Cancer-related Pain
- ClinicalTrials.gov ID
- NCT00726011
- Acronym / sponsor ID
- TEC-006OL / TEC-006OL
- Keywords
- due, cancer treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Wex Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Objectives: In cancer patients with moderate to severe pain who participated in the TEC-006 study:
Primary Objectives:
- 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 functioning).
- To assess the long-term safety and tolerability of subcutaneous tetrodotoxin (TTX).
Secondary Objective:
- To assess the duration of analgesia following repeated cycles of tetrodotoxin (TTX) treatment.
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 continuation study.
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.
Sample Size:
Up to 120 patients.
Investigational Product:
30ug TTX(Tetrodotoxin injectable) injected subcutaneously twice daily for 4 days.
Efficacy Variables:
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 Variables:
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 closed.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tetrodotoxin | Experimental | Biological: TetrodotoxinThere is only one arm; active treatment with TTX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- All patients who participated in the TEC-006 study (tetrodotoxin and placebo-treated) will be eligible for inclusion in this study provided they wish to continue to receive treatment and meet the inclusion and exclusion criteria.
- 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.
- A patient will be eligible or continue to be eligible for inclusion in this study (First Treatment Cycle and subsequent Treatment Cycles) only if all of the following criteria apply:
- Male or female 18 years of age and over
- In-patients or out-patients with a diagnosis of cancer
Key exclusion criteria (17 listed)
- A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetrodotoxinAlso: TTX30 µg twice daily for 4 days; repeated every two weeks as long as there is a meaningful analgesic response | Biological | Tetrodotoxin |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Neil Hagen, MD, FRCPC study chair
Tom Baker Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tetrodotoxin in people with Pain and Cancer, run by Wex Pharmaceuticals Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012.