Tension-Type HeadachePhase 2NCT00276952
Gonyautoxin in the Treatment of Chronic Tension-Type Headache
A Phase 2 study testing Gonyautoxin in people with Tension-Type Headache, run by University of Chile at 1 site in Chile.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Gonyautoxin
- How many people
- 27 participants
- Where
- 1 siteChile
- Study dates
- Sep 2004to Aug 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Use of headache prophylactic treatment a month prior to infiltration
- Myasthenic syndromes
- Muscular dystrophies
- Inflammatory myopathies
- Acute and chronic polineuropathies
Show all 10Show fewer
- Use of psychotropic substances 24-hour before infiltration
- Anticoagulant treatment
- terminal illnesses (AIDS, cancer)
- drugs or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Chile1 site
Departament of Neurology and Neurosurgery, Hospital Clínico Universidad de Chile.
Santiago, Santiago Metropolitan, 0
About this study
Official title: Phase 2 Study of Treatment of Chronic Tension-Type Headache Using Gonyautoxins
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
Read the 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
- Conditions
- Tension-Type Headache
- Being tested
- Gonyautoxin
- Keywords
- Gonyautoxins, Tension-type Headache, Human Treatment
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GonyautoxinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
a) Drop off in the patient acute headache pain (2 minutes, weekly for 20 weeks)
b) Number of days without headache pain following infiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startSep 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 27 participants
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Investigators
- Nestor Lagos, PhD, Principal investigator, Faculty of Medicine University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276952
- Sponsor's protocol ID
- HCUCH-NL-GTX-002
- Status last verified
- Sep 2005
- First submitted
- 12 Jan 2006
- Last updated
- 13 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Treatment of Chronic Tension-Type Headache Using Gonyautoxins
- ClinicalTrials.gov ID
- NCT00276952
- Acronym / sponsor ID
- HCUCH-NL-GTX-002
- Conditions
- Tension-Type Headache
- Keywords
- Gonyautoxins, Tension-type Headache, Human Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 27 participants
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Aug 2005
- First posted
- 13 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- Pregnancy
- Use of headache prophylactic treatment a month prior to infiltration
- Myasthenic syndromes
- Muscular dystrophies
- Inflammatory myopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gonyautoxin | Drug | – |
Primary outcome
a) Drop off in the patient acute headache pain (2 minutes, weekly for 20 weeks)
b) Number of days without headache pain following infiltration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nestor Lagos, PhD principal investigator
Faculty of Medicine University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gonyautoxin in people with Tension-Type Headache, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a) Drop off in the patient acute headache pain (2 minutes, weekly for 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2006.