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Evaluation of quantitative sensory testing (QST) using subcutaneous administration of single escalating doses of halneuron® (tetrodotoxin (TTX)) for injection in healthy volunteers

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500318-24-00
Enrollment
25
Registered
2023-07-21
Start date
2023-08-30
Completion date
2024-02-26
Last updated
2023-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pain

Brief summary

The change from baseline in all individual QST sensory measurements at 1-hour post-dose for each dose administered.

Detailed description

To compare the change at 1-hour post-dose from baseline in the different QST sensory test measurements between the two doses administered., The change from baseline of the odor identification and odor threshold test at 1 hour post-dose for each dose administered., The change from baseline in the hypoxic ventilatory response at 1-hour post-dose for each dose administered., To compare adverse events reported to changes in QST measurements

Interventions

DRUGHALNEURON® (Tetrodotoxin for Injection)

Sponsors

Leiden University Medical Center
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The change from baseline in all individual QST sensory measurements at 1-hour post-dose for each dose administered.

Secondary

MeasureTime frame
To compare the change at 1-hour post-dose from baseline in the different QST sensory test measurements between the two doses administered., The change from baseline of the odor identification and odor threshold test at 1 hour post-dose for each dose administered., The change from baseline in the hypoxic ventilatory response at 1-hour post-dose for each dose administered., To compare adverse events reported to changes in QST measurements

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026