COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Gonyautoxin in the Treatment of Chronic Tension-Type Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00276952
Recruitment Status : Terminated
First Posted : January 13, 2006
Last Update Posted : January 13, 2006
Information provided by:
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

Condition or disease Intervention/treatment Phase
Tension-Type Headache Drug: Gonyautoxin Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 2 Study of Treatment of Chronic Tension-Type Headache Using Gonyautoxins
Study Start Date : September 2004
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00276952

Layout table for location information
Departament of Neurology and Neurosurgery, Hospital Clínico Universidad de Chile.
Santiago, Chile, 0
Sponsors and Collaborators
University of Chile
Layout table for investigator information
Principal Investigator: Nestor Lagos, PhD Faculty of Medicine University of Chile
Layout table for additonal information Identifier: NCT00276952    
Other Study ID Numbers: HCUCH-NL-GTX-002
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: January 13, 2006
Last Verified: September 2005
Keywords provided by University of Chile:
Tension-type Headache
Human Treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Tension-Type Headache
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases