NCT00276952

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
Last Updated

January 13, 2006

Status Verified

September 1, 2005

First QC Date

January 12, 2006

Last Update Submit

January 12, 2006

Conditions

Tension-Type Headache

Keywords

GonyautoxinsTension-type HeadacheHuman Treatment

Outcome Measures

Primary Outcomes (2)

  • a) Drop off in the patient acute headache pain (2 minutes, weekly for 20 weeks)

  • b) Number of days without headache pain following infiltration

Interventions

GonyautoxinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departament of Neurology and Neurosurgery, Hospital Clínico Universidad de Chile.

Santiago, Santiago Metropolitan, 0, Chile

Location

MeSH Terms

Conditions

Tension-Type Headache

Interventions

gonyautoxins

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Nestor Lagos, PhD

    Faculty of Medicine University of Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

September 1, 2004

Study Completion

August 1, 2005

Last Updated

January 13, 2006

Record last verified: 2005-09

Locations

CL(1)