Expired Study
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Springfield, Missouri 65807


Purpose:

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


Study summary:

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.


Criteria:

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


NCT ID:

NCT00772473


Primary Contact:

Principal Investigator
Roger K Cady, M.D.
Clinvest


Backup Contact:

N/A


Location Contact:

Springfield, Missouri 65807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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