Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Correlation of Calcitonin Gene-Related Peptide (CGRP) Levels in Saliva With the Evolution of an Attack of Migraine
This study is currently recruiting participants.
Verified by Clinvest, October 2008
Sponsors and Collaborators: Clinvest
Merck
Information provided by: Clinvest
ClinicalTrials.gov Identifier: NCT00772473
  Purpose

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


Condition Intervention
Headache, Migraine
Other: subjects usual triptan treatment

Genetics Home Reference related topics: familial hemiplegic migraine
MedlinePlus related topics: Headache Migraine
Drug Information available for: Calcitonin Calcitonin human Fortical
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Correlation of Calcitonin Gene-Related Peptide (CGRP) Levels in Saliva With the Evolution of an Attack of Migraine

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

Biospecimen Description:

saliva


Estimated Enrollment: 30
Study Start Date: February 2008
Groups/Cohorts Assigned Interventions
1 group, usual acute triptan treatment Other: subjects usual triptan treatment
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772473

Contacts
Contact: Melody Knapp, LPN 417-841-3659 mknapp@clinvest.com
Contact: Deborah L Milligan, BS, RN 417-841-3625 dmilligan@clinvest.com

Locations
United States, Missouri
Clinvest Recruiting
Springfield, Missouri, United States, 65807
Contact: Deborah L Milligan, BS, RN     417-841-3625     dmilligan@clinvest.com    
Contact: Mary E Beech, LPN     417-841-3618     mbeech@clinvest.com    
Principal Investigator: Roger K Cady, M.D.            
Sub-Investigator: Curtis P Schreiber, M.D.            
Sponsors and Collaborators
Clinvest
Merck
  More Information

Responsible Party: Clinvest, A Division of Banyan Group, Inc ( Roger K. Cady, M.D. )
Study ID Numbers: Migraine IISP 33467
Study First Received: October 13, 2008
Last Updated: October 14, 2008
ClinicalTrials.gov Identifier: NCT00772473  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Calcitonin Gene-Related Peptide
Calcitonin
Migraine Disorders
Headache
Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases
Salmon calcitonin
Headache Disorders

Additional relevant MeSH terms:
Vasodilator Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009