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

Completed

• Conditions: Headache, Migraine
• Interventions: Other: subjects personal triptan

• Registration Number: NCT00772473
• Lead Sponsor: Clinvest

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-22
• Last Update Posted: 2009-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1 group, usual acute triptan treatment	subjects personal triptan	-

Primary Outcome Measures

Name	Time	Method
Compare baseline levels of CGRP measured during a migraine free period to those during the 4 phases (prodrome, mild, mod., severe) of migraine.	baseline,prodrome, mild, mod., severe, 4 hrs. post dose

Secondary Outcome Measures

Name	Time	Method
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.	screening, prodrome, pre-treatment, mild, moderate tosevere, post treatment

Trial Locations

Locations (1)

Clinvest; 🇺🇸 Springfield, Missouri, United States