Gonyautoxin in the Treatment of Chronic Tension-Type Headache - Tabular View

Tracking Information

First Received Date ^ICMJE

January 12, 2006

Last Updated Date

January 12, 2006

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Gonyautoxin in the Treatment of Chronic Tension-Type Headache

Official Title ^ICMJE

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

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Tension-Type Headache

Intervention ^ICMJE

Drug: Gonyautoxin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

August 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Chile

Administrative Information

NCT ID ^ICMJE

NCT00276952

Responsible Party

Study ID Numbers ^ICMJE

HCUCH-NL-GTX-002

Study Sponsor ^ICMJE

University of Chile

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Nestor Lagos, PhD

Faculty of Medicine University of Chile

Information Provided By

University of Chile

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP