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Trial record 39 of 231 for:    CALCITONIN SALMON

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00772473
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : May 25, 2009
Merck Sharp & Dohme Corp.
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Brief Summary:
To assess CGRP levels in saliva through the evolution of migraine.

Condition or disease Intervention/treatment
Headache, Migraine Other: subjects personal triptan

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.

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation of Calcitonin Gene-Related Peptide (CGRP) Levels in Saliva With the Evolution of an Attack of Migraine
Study Start Date : February 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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. [ Time Frame: screening, prodrome, pre-treatment, mild, moderate tosevere, post treatment ]

Biospecimen Retention:   None Retained

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at a mid west headache specialty clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00772473

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United States, Missouri
Springfield, Missouri, United States, 65807
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Principal Investigator: Roger K Cady, M.D. Clinvest

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Roger K. Cady, M.D., Clinvest, A Division of Banyan Group, Inc Identifier: NCT00772473     History of Changes
Other Study ID Numbers: Migraine IISP 33467
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: May 25, 2009
Last Verified: May 2009
Additional relevant MeSH terms:
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Salmon calcitonin
Calcitonin Gene-Related Peptide
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents