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 Sharp & Dohme Corp.
Information provided by:
Clinvest
ClinicalTrials.gov Identifier:
NCT00772473
First received: October 13, 2008
Last updated: May 22, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention
Headache, Migraine
Other: subjects personal triptan

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Clinvest:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

saliva


Enrollment: 34
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 group, usual acute triptan treatment Other: subjects personal triptan
Subjects will treat 1 migraine attack with their usual 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients at a mid west headache specialty clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772473

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

No publications provided by Clinvest

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roger K. Cady, M.D., Clinvest, A Division of Banyan Group, Inc
ClinicalTrials.gov Identifier: NCT00772473     History of Changes
Other Study ID Numbers: Migraine IISP 33467
Study First Received: October 13, 2008
Last Updated: May 22, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Calcitonin Gene-Related Peptide
Calcitonin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014