Tetrodotoxin and quantitative sensory testing in healthy volunteers
| ISRCTN | ISRCTN78737401 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78737401 |
| EudraCT/CTIS number | 2022-500318-24-00 |
- Submission date
- 18/08/2023
- Registration date
- 20/09/2023
- Last edited
- 20/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
This research is a type of medical study which is in the second stage of testing. The main goal is to understand how a substance called Halneuron (also known as tetrodotoxin) affects the nerves in the peripheral nervous system in the body. The researchers will use a special test called Quantitative Sensory Testing (QST) to measure these effects. The information learned from this study will help create a detailed set of tests that can be used to check the analgesic efficacy in patients who experience pain.
Who can participate?
Healthy volunteers aged between 18 and 55 years old
What does the study involve?
Participants will be administered two doses of Halneuron (tetrodotoxin) subcutaneously.
What are the possible benefits and risks of participating?
The benefit of this study outweighs the risks for individual subjects and the clinical study as a whole. Halneuron has already been tested at the intended doses in clinical studies in healthy subjects without serious or severe adverse events.
Where is the study run from?
Leiden University Medical Center (LUMC) (The Netherlands)
When is the study starting and how long is it expected to run for?
March 2022 to March 2024
Who is funding the study?
WEX Pharmaceuticals Inc (Canada)
Who is the main contact?
Kiki Kuijpers, k.w.k.kuijpers@lumc.nl (The Netherlands)
Contact information
Public
Albinusdreef 2
Leiden
2333ZA
Netherlands
 ORCID ID |
0000-0002-1025-9476 |
|---|---|
| Phone | +31715263537 |
| k.w.k.kuijpers@lumc.nl |
Scientific
Albinusdreef 2
Leiden
2333ZA
Netherlands
| Phone | +31715263537 |
|---|---|
| k.w.k.kuijpers@lumc.nl |
Principal Investigator
Albinusdreef 2
Leiden
2332 ZA
Netherlands
| Phone | +31715262301 |
|---|---|
| a.dahan@lumc.nl |
Study information
| Study design | Single-centre single-escalating-dose study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Evaluation of quantitative sensory testing (QST) Using subcutaneous administration of single escalating doses of Halneuron® (tetrodotoxin (TTX) for injection) in healthy volunteers |
| Study acronym | TETRO |
| Study objectives | The study aims to develop a sensitive test battery that can be applied to assess analgesic efficacy in pain patients |
| Ethics approval(s) |
Approved 21/07/2023, Medical Ethics Review Committee Leiden The Hague Delft (Albinusdreef 2, Leiden, 2333ZA, Netherlands; +31(0)715263241; metc-ldd@lumc.nl), ref: P23.048 |
| Health condition(s) or problem(s) studied | Pain |
| Intervention | In this study, two doses of Halneuron (tetrodotoxin) will be administered subcutaneously. During this study, there will be no randomization. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Dose response |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Tetrodotoxin |
| Primary outcome measure | Sensation and pain thresholds measured using Quantitative Sensory Testing (QST) after two different doses of Halneuron (Tetrodotoxin (TTX) for Injection) |
| Secondary outcome measures | None provided |
| Overall study start date | 01/03/2022 |
| Completion date | 01/03/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Both |
| Target number of participants | 25 |
| Key inclusion criteria | 1. Aged 18 to 55 years old (inclusive) 2. Body mass index (BMI) within 19-30 kg/m2 3. Subjects will be healthy according to physical examination (including vital signs) and normal laboratory tests (hematology, biochemistry, urinalysis) including, as well as a negative screening of ethyl alcohol and drugs of abuse in urine. |
| Key exclusion criteria | Not meeting the participant inclusion criteria |
| Date of first enrolment | 01/09/2023 |
| Date of final enrolment | 01/02/2024 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden
233 ZA
Netherlands
Sponsor information
Hospital/treatment centre
Albinusdreef 2
Leiden
2333 ZA
Netherlands
| Phone | +3171-5263359 |
|---|---|
| pijnonderzoek@lumc.nl | |
| Website | https://www.lumc.nl/?setlanguage=English&setcountry=en |
"ROR" |
https://ror.org/05xvt9f17 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the confidentiality of these data. |
Editorial Notes
31/08/2023: Trial's existence confirmed by the Medical Ethics Review Committee Leiden The Hague Delft (Netherlands).
