Gonyautoxin in the Treatment of Chronic Tension-Type Headache

Phase 2

Terminated

• Conditions: Tension-Type Headache

• Registration Number: NCT00276952
• Lead Sponsor: University of Chile

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

Study Timeline

• Study Start: 2004-09
• Study Completion: 2005-08
• Status Verified: 2005-09
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Last Update Submitted: 2006-01-12
• Study First Posted: 2006-01-13
• Last Update Posted: 2006-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Departament of Neurology and Neurosurgery, Hospital Clínico Universidad de Chile.; 🇨🇱 Santiago, Chile