Gonyautoxin in the Treatment of Chronic Tension-Type Headache

Phase 2TerminatedNCT00276952

University of Chile27 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tension-Type Headache

Interventions

GonyautoxinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Departament of Neurology and Neurosurgery, Hospital Clínico Universidad de Chile.

Santiago, Santiago Metropolitan, Chile

Outcomes

Primary Outcomes

a) Drop off in the patient acute headache pain (2 minutes, weekly for 20 weeks)

b) Number of days without headache pain following infiltration

Data from ClinicalTrials.gov

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