Expired Study
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Springfield, Missouri 65807


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

Migraine IISP 33467


NCT ID:

NCT00772473


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Clinvest


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

34


Enrollment Type:

Actual


Overall Contact Information

Official Name:Roger K Cady, M.D.
Principal Investigator
Clinvest

Study Dates

Start Date:February 2008
Completion Date:January 2009
Completion Type:Actual
Primary Completion Date:January 2009
Primary Completion Type:Actual
Verification Date:May 2009
Last Changed Date:May 22, 2009
First Received Date:October 13, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:subjects personal triptan
Description:Subjects will treat 1 migraine attack with their usual triptan
Arm Name:1 group, usual acute triptan treatment

Study Arms

Study Arm Type:Other
Arm Name:1 group, usual acute triptan treatment

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Clinvest
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Merck

Samples and Retentions

Sample Retention:None Retained
Description: saliva
Study Population: Patients at a mid west headache specialty clinic
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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