Status:
COMPLETED
Correlation of Calcitonin Gene-Related Peptide (CGRP) Levels in Saliva With the Evolution of an Attack of Migraine
Lead Sponsor:
Clinvest
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Headache, Migraine
Eligibility:
All Genders
18-65 years
Brief Summary
To assess CGRP levels in saliva through the evolution of migraine.
Detailed Description
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 seve...
Eligibility Criteria
Inclusion
- Ability to read, understand, and sign the informed consent
- Subject is between the ages of 18 and 65, either male or female
- Negative pregnancy test for those of childbearing potential.
- Adequate birth control as approved by the investigator if of childbearing potential
- 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
- Pregnant or breast feeding
- Presence of any condition or symptoms that would knowingly alter the content of the saliva
- Presence of any medical disease or condition that would interfere with the conduct of the study
- 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
- Use of migraine preventive medications in the three months prior to screening
- History of drug or alcohol abuse that would interfere with the study
- Any pathology of the salivary glands such as sialadenitis (e.g., Sjorgen's syndrome, viral or bacterial sialadenitis, obstructive sialadentitis)
- History of hypersensitivity or allergy to triptan medications
- Presence of diabetes, salivary gland tumors, liver disease, alcoholism, and neuropathy
- More than 15 days per month of headache within the past 3 months
- Participation in another investigative drug study within the past 30 days
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00772473
Start Date
February 1 2008
End Date
January 1 2009
Last Update
May 25 2009
Active Locations (1)
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1
Clinvest
Springfield, Missouri, United States, 65807