|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00276952 |
|
Date of registration:
|
12/01/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Gonyautoxin in the Treatment of Chronic Tension-Type Headache
|
|
Scientific title:
|
Phase 2 Study of Treatment of Chronic Tension-Type Headache Using Gonyautoxins |
|
Date of first enrolment:
|
September 2004 |
|
Target sample size:
|
27 |
|
Recruitment status: |
Terminated |
|
URL:
|
http://clinicaltrials.gov/show/NCT00276952 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Chile
| | | | | | | |
|
Contacts
|
|
Name:
|
Nestor Lagos, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Faculty of Medicine University of Chile |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Tension-Type Headache
|
|
Intervention(s)
|
|
Drug: Gonyautoxin
|
|
Primary Outcome(s)
|
|
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 ID(s)
|
|
HCUCH-NL-GTX-002
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|