Gonyautoxin in the Treatment of Chronic Tension-Type Headache

Phase 2 Study of Treatment of Chronic Tension-Type Headache Using Gonyautoxins

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00276952

Enrollment

Registered

2006-01-13

Start date

2004-09-30

Completion date

2005-08-31

Last updated

2006-01-13

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

Conditions

Tension-Type Headache

Keywords

Gonyautoxins, Tension-type Headache, Human Treatment

Brief summary

The purpose of this study is to evaluate the clinical efficacy of Gonyautoxin 2/3 epimers in the treatment of patients diagnosed with chronic tensional-type headache in accordance with International Headache Society guidelines

Detailed description

Gonyautoxin are phycotoxins, whose molecular mechanism of action is a reversible block of the voltage-gated sodium channels at neuronal level. They are axonal conduction blockers impeding nerve impulse propagation. In order to evaluate the clinical efficacy of Gonyautoxin 2/3 epimers in the treatment of patients diagnosed with chronic tensional-type headache, the patients were locally injected with placebo versus Gonyautoxin following a painful spots injection standarized protocol

Interventions

DRUGGonyautoxin

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Chronic tensional-type headache patients according to the International Headache Society criteria: patients with headache of a pressing or tightening quality with episodic frequency above 15 days a month * Refractory to conventional treatments such as, orally administered analgesics, systemic muscular relaxant, corticoids and antidepressant like Amytriptiline * Treated and controlled in the University Hospital Neurology Clinic over 2 years with duration of symptoms over 3 years

Exclusion criteria

* Pregnancy * Use of headache prophylactic treatment a month prior to infiltration * Myasthenic syndromes * Muscular dystrophies * Inflammatory myopathies * Acute and chronic polineuropathies * Use of psychotropic substances 24-hour before infiltration * Anticoagulant treatment * terminal illnesses (AIDS, cancer) * drugs or alcohol abuse

Design outcomes

Primary

Measure	Time frame
a) Drop off in the patient acute headache pain (2 minutes, weekly for 20 weeks)	—
b) Number of days without headache pain following infiltration	—

Countries

Chile

Outcome results

None listed

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