Gonyautoxin in the Treatment of Chronic Tension-Type Headache

Tension-Type Headache Clinical Trial

Official title:

Phase 2 Study of Treatment of Chronic Tension-Type Headache Using Gonyautoxins

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00276952
• Other study ID #: HCUCH-NL-GTX-002
• Status: Terminated
• Phase: Phase 2
• First received: January 12, 2006
• Last updated: January 12, 2006
• Start date: September 2004
• Est. completion date: August 2005

Study information

• Verified date: September 2005
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

Drug:
• Gonyautoxin

Locations

Country	Name	City	State
Chile	Departament of Neurology and Neurosurgery, Hospital Clínico Universidad de Chile.	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a) Drop off in the patient acute headache pain (2 minutes, weekly for 20 weeks)
Primary	b) Number of days without headache pain following infiltration