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Gonyautoxin in the Treatment of Chronic Tension-Type Headache

This study has been terminated.

Sponsored by: 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

MedlinePlus related topics:   Headache   

ChemIDplus related topics:   Gonyautoxin   

U.S. FDA Resources

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

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

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

Keywords provided by University of Chile:
Gonyautoxins  
Tension-type Headache  
Human Treatment  

Study placed in the following topic categories:
Signs and Symptoms
Tension-Type Headache
Headache
Central Nervous System Diseases
Neurologic Manifestations
Headache Disorders, Primary
Pain
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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