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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00772473
Other study ID # Migraine IISP 33467
Secondary ID
Status Completed
Phase N/A
First received October 13, 2008
Last updated May 22, 2009
Start date February 2008
Est. completion date January 2009

Study information

Verified date May 2009
Source Clinvest
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
subjects personal triptan
Subjects will treat 1 migraine attack with their usual triptan

Locations

Country Name City State
United States Clinvest Springfield Missouri

Sponsors (2)

Lead Sponsor Collaborator
Clinvest Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare baseline levels of CGRP measured during a migraine free period to those during the 4 phases (prodrome, mild, mod., severe) of migraine. baseline,prodrome, mild, mod., severe, 4 hrs. post dose No
Secondary 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. screening, prodrome, pre-treatment, mild, moderate tosevere, post treatment No
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