Ignite Creation Date:
2024-05-06 @ 1:50 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01916395
Status:
COMPLETED
Last Update Posted:
2013-08-05
First Post:
2013-08-02
Brief Title:
Comparison of Treximet Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache
Sponsor:
Gary E Ruoff MD
Organization:
Westside Family Medical Center PC
Study Overview
Official Title:
Comparison of Treximet and Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to determine whether inflammatory markers such as C-Reactive Protein CRP Calcitonin Gene-Related Peptide CGRP Vasoactive Intestinal Polypeptide VIP or Substance P SP are reduced in patients having a migraine headache when treated with Imitrex or Treximet
The secondary objective is to determine the effects of Imitrex and Treximet on C-Reactive Protein CRP in patients with active migraine headaches
The secondary objective is to determine the effects of Imitrex and Treximet on C-Reactive Protein CRP in patients with active migraine headaches
Detailed Description:
Migraine is a neurovascular process involving the brain and related structures Neuroinflammatory substances such as CRP CGRP VIP SP and prostaglandins are liberated during the migraine Elevation of these markers may be associated with other conditions which contain an inflammatory component such as coronary artery disease VIP is an inflammation and pain transmission and thus are markers of sensory nociceptive neurons
During this study the subjects will have the following inflammation markers analyzed C-Reactive Protein CRP Calcitonin Gene-Related Peptide CGRP Vasoactive Intestinal Polypeptide VIP and Substance P SP
During this study the subjects will have the following inflammation markers analyzed C-Reactive Protein CRP Calcitonin Gene-Related Peptide CGRP Vasoactive Intestinal Polypeptide VIP and Substance P SP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None