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

NCT00772473 | Completed

• 1 other identifier: Migraine IISP 33467
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Headache, Migraine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

1 group, usual acute triptan treatment

Other: subjects personal triptan

Interventions

subjects personal triptan OTHER

Subjects will treat 1 migraine attack with their usual triptan

1 group, usual acute triptan treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at a mid west headache specialty clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinvest: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Clinvest

Springfield, Missouri, 65807, United States

Location

Related Publications (1)

• 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.

  PMID: 19788468 DERIVED

Biospecimen

Retention: NONE RETAINED

saliva

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Roger K Cady, M.D.

  Clinvest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 25, 2009

Record last verified: 2009-05

Locations

US (1)