Gonyautoxin in the Treatment of Chronic Tension-Type Headache - Full Text View

Sponsor:	University of Chile
Information provided by:	University of Chile
ClinicalTrials.gov Identifier:	NCT00276952

Purpose

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

Condition	Intervention	Phase
Tension-Type Headache	Drug: Gonyautoxin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of Treatment of Chronic Tension-Type Headache Using Gonyautoxins

Resource links provided by NLM:

MedlinePlus related topics: Headache

Drug Information available for: Gonyautoxin

U.S. FDA Resources

Further study details as provided by University of Chile:

Primary Outcome Measures:

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

Estimated Enrollment:	27
Study Start Date:	September 2004
Estimated Study Completion Date:	August 2005

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276952

Locations

Chile
Departament of Neurology and Neurosurgery, Hospital Clínico Universidad de Chile.
Santiago, Chile, 0

Sponsors and Collaborators

University of Chile

Investigators

Principal Investigator:

Nestor Lagos, PhD

Faculty of Medicine University of Chile

More Information

No publications provided

Study ID Numbers:	HCUCH-NL-GTX-002
Study First Received:	January 12, 2006
Last Updated:	January 12, 2006
ClinicalTrials.gov Identifier:	NCT00276952 History of Changes
Health Authority:	Chile: Instituto de Salud Publica de Chile

Keywords provided by University of Chile:

Gonyautoxins
Tension-type Headache
Human Treatment

Additional relevant MeSH terms:

Signs and Symptoms
Tension-Type Headache
Nervous System Diseases
Headache
Central Nervous System Diseases

Neurologic Manifestations
Headache Disorders, Primary
Pain
Brain Diseases
Headache Disorders

ClinicalTrials.gov processed this record on November 09, 2009