Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094068
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-10-09
Brief Title:
The Effect of Sildenafil Citrate Viagra Registered Trademark on Brain Blood Flow in Multiple Sclerosis Patients
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study to Detect the Effect of Sildenafil Citrate on Cerebral Blood Perfusion in Multiple Sclerosis Patients by Perfusion MRI
Status:
COMPLETED
Status Verified Date:
2006-05
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:
This study will determine whether sildenafil citrate commonly known as Viagra can cause increased blood flow to the brain in a wide range of multiple sclerosis MS patients including women Although people with MS can have reduced blood flow in the brain as part of the disease process it has been observed that men with MS may have increased blood flow to the brain while taking sildenafil citrate This study will measure brain blood flow or blood volume in men and women with MS before and after taking Viagra and compare the results to those in healthy volunteers in an effort to better understand the disease
Healthy volunteers 18 years of age and older and patients with MS between 18 and 55 years of age may be eligible for this study Volunteers are screened with a medical history and physical examination and patients with MS are evaluated with a complete neurological examination and screening for heart disease including history of chest pain heart attack and use of nitrates
Participants undergo magnetic resonance imaging MRI before and after taking Viagra During the scanning subjects lie still on a table that can slide in and out of the cylindrical metal scanner Scanning time varies from 20 minutes to 3 hours with most scans lasting between 45 and 90 minutes First a scan is obtained of the carotid arteries major arteries in the neck supplying blood to the brain to determine if the arteries are narrowed and then baseline MRI scans and measures of brain blood flow are obtained The subject then comes out of the scanner and takes a Viagra pill After 1 hour the subject returns to the scanner and more scans are obtained to determine changes in brain blood flow and blood volume following Viagra
A catheter thin plastic tube is placed in the subjects arm before he or she enters the magnet for the second time for injection of a contrast agent called gadolinium DTPA which allows brain structures to be distinguished more clearly
Healthy volunteers 18 years of age and older and patients with MS between 18 and 55 years of age may be eligible for this study Volunteers are screened with a medical history and physical examination and patients with MS are evaluated with a complete neurological examination and screening for heart disease including history of chest pain heart attack and use of nitrates
Participants undergo magnetic resonance imaging MRI before and after taking Viagra During the scanning subjects lie still on a table that can slide in and out of the cylindrical metal scanner Scanning time varies from 20 minutes to 3 hours with most scans lasting between 45 and 90 minutes First a scan is obtained of the carotid arteries major arteries in the neck supplying blood to the brain to determine if the arteries are narrowed and then baseline MRI scans and measures of brain blood flow are obtained The subject then comes out of the scanner and takes a Viagra pill After 1 hour the subject returns to the scanner and more scans are obtained to determine changes in brain blood flow and blood volume following Viagra
A catheter thin plastic tube is placed in the subjects arm before he or she enters the magnet for the second time for injection of a contrast agent called gadolinium DTPA which allows brain structures to be distinguished more clearly
Detailed Description:
Advances in MR perfusion imaging have provided clinical researchers with the opportunity to quantify regional cerebral blood flow CBF It has been shown that cerebral perfusion in patients with multiple sclerosis MS is reduced particularly in the grey matter However preliminary data in a small number of male secondary progressive SP MS patients with erectile dysfunction suggests that sildenafil citrate Viagra Registered Trademark helps to increase grey matter perfusion The purpose of this study is to extend these findings to male MS patients without erectile dysfunction and female MS patients by comparing CBF measures of MS patients of both sexes to age and gender-matched healthy controls CBF will be measured before and one hour after taking sildenafil citrate
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 |
|---|---|---|---|
| 05-CC-0003 | None | None | None |