Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255320
Status:
COMPLETED
Last Update Posted:
2005-12-09
First Post:
2005-11-16
Brief Title:
Experimental Headache Induced by Vasoactive Intestinal Polypeptide
Sponsor:
Danish Headache Center
Organization:
Danish Headache Center
Study Overview
Official Title:
Experimental Headache Induced by Vasoactive Intestinal Polypeptide
Status:
COMPLETED
Status Verified Date:
2003-12
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:
We hypothesized that infusion of VIP may induce headache in healthy subjects and that VIP induced headache may be associated with dilatation of intra- and extracerebral blood vessels To test this hypothesis we performed a double blind placebo controlled crossover study in normal human volunteers and studied the effect on headache and cerebral as well as hemodynamic parameters
Detailed Description:
We hypothesized that infusion of VIP may induce headache in healthy subjects and that VIP induced headache may be associated with dilatation of intra- and extracerebral blood vessels To test this hypothesis we performed a double blind placebo controlled crossover study in normal human volunteers and studied the effect on headache and cerebral as well as hemodynamic parameters In a double-blind placebo-controlled crossover design the subjects were randomly allocated to receive 8 pmolkgmin VIP or placebo isotonic saline over 25 min Headache intensity Mean velocity of blood flow in the middle cerebral artery VmeanMCA superfical temporal artery diameter PetCO2 adverse events and vital signs were recorded at T-10 T0 and then every 10 min until 120 min after start of infusion Single photon emission computerized tomography SPECT was performed at T-0 T20 and T60
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