Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208065
Status:
COMPLETED
Last Update Posted:
2009-05-06
First Post:
2005-09-13
Brief Title:
Evaluation of Histamine CGRP and VIP as Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers
Sponsor:
Clinvest
Organization:
Clinvest
Study Overview
Official Title:
Evaluation of Histamine CGRP and VIP as Biological Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers in Response to Sinus Symptoms
Status:
COMPLETED
Status Verified Date:
2009-05
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 of this study is to evaluate histamine CGRP and VIP levels in saliva as biological markers for activation of trigeminal and parasympathetic nerve fibers in various clinical presentations of primary headaches compared to allergic rhinosinusitis and control populations
Detailed Description:
It has been suggested that many people with self-diagnosed or physician diagnosed sinus headache experience symptoms that fulfill diagnostic criteria for migraine or migrainous headache The shared symptomatology does not differentiate these disordersSinus symptoms as an early manifestation of migraine may be associated with elevated levels of CGRP suggesting peripheral trigeminal activation whereas sinus symptoms late in migraine may have associated elevations of VIP suggesting parasymptathetic activation Subjects without autonomic or sinus symptoms will not have changes in salivatory histamine CGRP or VIP and will have values similar to controls Subjects with rhinosinusitis will have levels or patterns of salivatory histamine CGRP and VIP unique from migraine subjects If sinus symptoms are associated with parasympathetic activation then there should be detectable increases in VIP early in the course of nasal symptom development and conversely if these symptoms associate with trigeminal activation then increases in CGRP should be detected Five groups of 10 subjects each will be recruited Group A without migraine with self-described sinus headache or symptoms of rhinosinusitis Group B with chronic rhinosinusitis and no history of migraine or sinus headache Group C with sinus headache with symptoms meeting IHS criteria for migraine and symptoms of rhinosinusitis preceding the onset of headache symptoms meeting migraine criteria Group D with symptoms of rhinosinusitis that develop late in the course of migraine after criteria for IHS migraine are met Group E with IHS migraine without sinus symptoms associated with migraine
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAPSS-321 | None | None | None |