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

May 22, 2009 updated by: Clinvest
To assess CGRP levels in saliva through the evolution of migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients at a mid west headache specialty clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 group, usual acute triptan treatment
Other: subjects personal triptan
Subjects will treat 1 migraine attack with their usual triptan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline,prodrome, mild, mod., severe, 4 hrs. post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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
screening, prodrome, pre-treatment, mild, moderate tosevere, post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinvest

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Roger K Cady, M.D., Clinvest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

October 13, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

May 25, 2009

Last Update Submitted That Met QC Criteria

May 22, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Migraine IISP 33467

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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