Gonyautoxin in the Treatment of Chronic Tension-Type Headache

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-08-31

Brief Summary

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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

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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

Conditions

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Tension-Type Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Gonyautoxin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Nestor Lagos, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine University of Chile

Locations

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

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

Other Identifiers

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HCUCH-NL-GTX-002

Identifier Type: -

Identifier Source: org_study_id