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Gonyautoxin in the Treatment of Chronic Tension-Type Headache

U

University of Chile

Status and phase

Terminated
Phase 2

Conditions

Tension-Type Headache

Treatments

Drug: Gonyautoxin

Study type

Interventional

Funder types

Other

Identifiers

NCT00276952
HCUCH-NL-GTX-002

Details and patient eligibility

About

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

Full 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

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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