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

Headache, Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772473
• Other study ID #: Migraine IISP 33467
• Status: Completed
• Phase: N/A
• First received: October 13, 2008
• Last updated: May 22, 2009
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: May 2009
• Source: Clinvest
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Headache, Migraine
• Migraine Disorders

Intervention

Other:
• subjects personal triptan
Subjects will treat 1 migraine attack with their usual triptan

Locations

Country	Name	City	State
United States	Clinvest	Springfield	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Clinvest	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No