Correlation of Calcitonin Gene-Related Peptide (CGRP) Levels in Saliva With the Evolution of an Attack of Migraine

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Clinvest
ClinicalTrials.gov Identifier:
NCT00772473
First received: October 13, 2008
Last updated: May 22, 2009
Last verified: May 2009

October 13, 2008
May 22, 2009
February 2008
January 2009   (final data collection date for primary outcome measure)
Compare baseline levels of CGRP measured during a migraine free period to those during the 4 phases (prodrome, mild, mod., severe) of migraine. [ Time Frame: baseline,prodrome, mild, mod., severe, 4 hrs. post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00772473 on ClinicalTrials.gov Archive Site
CGRP levels compared to no headache and as function of prodrome symptoms, prediction of mod/sev headache; compare prodrome symptoms to those reported at screening to pre-tx,tx,post tx. [ Time Frame: screening, prodrome, pre-treatment, mild, moderate tosevere, post treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Correlation of Calcitonin Gene-Related Peptide (CGRP) Levels in Saliva With the Evolution of an Attack of Migraine
Correlation of Calcitonin Gene-Related Peptide (CGRP) Levels in Saliva With the Evolution of an Attack of Migraine

To assess CGRP levels in saliva through the evolution of migraine.

The release of CGRP is assumed to be initiated early in the migraine process and increases as the headache intensifies. Levels of CGRP will be measured during the premonitory, mild, moderate, and severe phases of a single migraine attack and compared to the baseline value determined when the subject was headache free. Understanding of the clinical evolution of migraine CGRP release may have significant implications in acute treatment.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

saliva

Non-Probability Sample

Patients at a mid west headache specialty clinic

Headache, Migraine
Other: subjects personal triptan
Subjects will treat 1 migraine attack with their usual triptan
1 group, usual acute triptan treatment
Intervention: Other: subjects personal triptan
Cady RK, Vause CV, Ho TW, Bigal ME, Durham PL. Elevated saliva calcitonin gene-related peptide levels during acute migraine predict therapeutic response to rizatriptan. Headache. 2009 Oct;49(9):1258-66.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
January 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Ability to read, understand, and sign the informed consent
  2. Subject is between the ages of 18 and 65, either male or female
  3. Negative pregnancy test for those of childbearing potential.
  4. Adequate birth control as approved by the investigator if of childbearing potential
  5. Subjects must fulfill criteria for IHS migraine (1.1 or 1.2) with a history of 1-6 migraines per month within the past 3 months and at least 15 headache free days though out the previous three month time period

Exclusion Criteria:

  1. Pregnant or breast feeding
  2. Presence of any condition or symptoms that would knowingly alter the content of the saliva
  3. Presence of any medical disease or condition that would interfere with the conduct of the study
  4. Current use of other medications that would be contraindicated in those patients that will take triptan medications for treatment of migraine symptoms, ie. MAO inhibitors, lithium, methyergonovine, methysergide, or ergotamine-containing products
  5. Use of migraine preventive medications in the three months prior to screening
  6. History of drug or alcohol abuse that would interfere with the study
  7. Any pathology of the salivary glands such as sialadenitis (e.g., Sjorgen's syndrome, viral or bacterial sialadenitis, obstructive sialadentitis)
  8. History of hypersensitivity or allergy to triptan medications
  9. Presence of diabetes, salivary gland tumors, liver disease, alcoholism, and neuropathy
  10. More than 15 days per month of headache within the past 3 months
  11. Participation in another investigative drug study within the past 30 days
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00772473
Migraine IISP 33467
No
Roger K. Cady, M.D., Clinvest, A Division of Banyan Group, Inc
Clinvest
Merck Sharp & Dohme Corp.
Principal Investigator: Roger K Cady, M.D. Clinvest
Clinvest
May 2009

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