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Gonyautoxin in the Treatment of Chronic Tension-Type Headache

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ClinicalTrials.gov Identifier: NCT00276952
Recruitment Status : Terminated
First Posted : January 13, 2006
Last Update Posted : January 13, 2006
Sponsor:
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

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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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00276952


Locations
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Chile
Departament of Neurology and Neurosurgery, Hospital Clínico Universidad de Chile.
Santiago, Chile, 0
Sponsors and Collaborators
University of Chile
Investigators
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Principal Investigator: Nestor Lagos, PhD Faculty of Medicine University of Chile

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ClinicalTrials.gov Identifier: NCT00276952     History of Changes
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:
Gonyautoxins
Tension-type Headache
Human Treatment

Additional relevant MeSH terms:
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Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases