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

NCT ID: NCT00772473

Last Updated: 2009-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-01-31

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 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.

Conditions

Headache, Migraine

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

1 group, usual acute triptan treatment

subjects personal triptan

Intervention Type: OTHER

Subjects will treat 1 migraine attack with their usual triptan

Interventions

subjects personal triptan

Subjects will treat 1 migraine attack with their usual triptan

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Clinvest

OTHER

Sponsor Role: lead

Responsible Party

Clinvest, A Division of Banyan Group, Inc

Principal Investigators

Roger K Cady, M.D.

Role: PRINCIPAL_INVESTIGATOR

Clinvest

Locations

Clinvest

Springfield, Missouri, United States

Countries

United States

References

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. doi: 10.1111/j.1526-4610.2009.01523.x.

Reference Type: DERIVED

PMID: 19788468 (View on PubMed)

Other Identifiers

Migraine IISP 33467

Identifier Type: -

Identifier Source: org_study_id