Back to resultsGonyautoxin in the Treatment of Chronic Tension-Type Headache
Primary Purpose
Tension-Type Headache
Status
Terminated
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Gonyautoxin
Sponsored by
About this trial
This is an interventional treatment trial for Tension-Type Headache focused on measuring Gonyautoxins, Tension-type Headache, Human Treatment
Eligibility 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
Sites / Locations
- Departament of Neurology and Neurosurgery, Hospital Clínico Universidad de Chile.
Outcomes
Primary Outcome Measures
a) Drop off in the patient acute headache pain (2 minutes, weekly for 20 weeks)
b) Number of days without headache pain following infiltration
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00276952
Brief Title
Gonyautoxin in the Treatment of Chronic Tension-Type Headache
Official Title
Phase 2 Study of Treatment of Chronic Tension-Type Headache Using Gonyautoxins
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Terminated
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Chile
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache
Keywords
Gonyautoxins, Tension-type Headache, Human Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
27 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gonyautoxin
Primary Outcome Measure Information:
Title
a) Drop off in the patient acute headache pain (2 minutes, weekly for 20 weeks)
Title
b) Number of days without headache pain following infiltration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nestor Lagos, PhD
Organizational Affiliation
Faculty of Medicine University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departament of Neurology and Neurosurgery, Hospital Clínico Universidad de Chile.
City
Santiago
ZIP/Postal Code
0
Country
Chile
12. IPD Sharing Statement
Learn more about this trial
Gonyautoxin in the Treatment of Chronic Tension-Type Headache
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