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

This study has been completed.

Sponsor:

Collaborator:

Merck

Information provided by:

Clinvest

ClinicalTrials.gov Identifier:

NCT00772473

First received: October 13, 2008

Last updated: May 22, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 13, 2008

Last Updated Date

May 22, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Compare baseline levels of CGRP measured during a migraine free period to those during the 4 phases (prodrome, mild, mod., severe) of migraine. [ Time Frame: baseline,prodrome, mild, mod., severe, 4 hrs. post dose ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00772473 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: screening, prodrome, pre-treatment, mild, moderate tosevere, post treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: None Retained

Description:

saliva

Sampling Method

Non-Probability Sample

Study Population

Patients at a mid west headache specialty clinic

Condition ^ICMJE

Headache, Migraine

Intervention ^ICMJE

Other: subjects personal triptan

Subjects will treat 1 migraine attack with their usual triptan

Study Group/Cohort (s)

1 group, usual acute triptan treatment

Intervention: Other: subjects personal triptan

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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 Criteria:

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00772473

Other Study ID Numbers ^ICMJE

Migraine IISP 33467

Has Data Monitoring Committee

Responsible Party

Roger K. Cady, M.D., Clinvest, A Division of Banyan Group, Inc

Study Sponsor ^ICMJE

Clinvest

Collaborators ^ICMJE

Merck

Investigators ^ICMJE

Principal Investigator:

Roger K Cady, M.D.

Clinvest

Information Provided By

Clinvest

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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