Local Anesthetic Properties of Neosaxitoxin

Phase 1 Study of Local Infiltration of Neosaxitoxin as a Local Anesthetic

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00273065

Enrollment

Registered

2006-01-09

Start date

2005-05-31

Completion date

2005-09-30

Last updated

2007-02-19

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

Conditions

Healthy Volunteers

Keywords

Local Anesthetic, Neosaxitoxin

Brief summary

The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans

Detailed description

Neosaxitoxin is a phycotoxins that reversible block the voltage-gated sodium channels at neuronal level. Its activity is express as blocking the axonal conduction, stopping the propagation of the nerve impulse. The objective of the present work is to evaluate the neosaxitoxin efficacy and safety as local anesthetic in a human trial Methods: Randomized, double-blind, placebo-controlled trial, with 10 healthy volunteers. The anesthetic effect will be evaluated using a standardized human sensory and pain model. TSA Neurosensory analyser and Von Frey Technique will be used to evaluate five parameters: sensory threshold for warm and cold, pain thresholds for heat and cold and mechanical touch perception threshold.

Interventions

DRUGNeosaxitoxin

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy males with the abilities to understand and respond the tests to perform

Exclusion criteria

* Use of any oral analgesics at least ten days before the study * Drugs abuse history * Showing at the clinical examination any signal of psychiatric disorder

Design outcomes

Primary

Measure	Time frame
Measurements at 1,3,6,9,12,16,24 and 48 hrs after the injections	—
pain thresholds for heat	—
pain thresholds for cold	—
mechanical touch perception threshold	—
Neural blockade of five parameters:	—
sensory threshold for warm	—
sensory threshold for cold	—

Secondary

Measure	Time frame
Blood sample at 1 hour	—
Orine sample at 4 hours after the injection, in order to determine amounts of neosaxitoxin	—
Pain on injection (VAS Score 0-10)	—

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026