The Effect of Sildenafil Citrate (Viagra® (Registered Trademark)) on Brain Blood Flow in Multiple Sclerosis Patients
|First Received Date ICMJE||October 9, 2004|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||October 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00094068 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Effect of Sildenafil Citrate (Viagra® (Registered Trademark)) on Brain Blood Flow in Multiple Sclerosis Patients|
|Official Title ICMJE||A Pilot Study to Detect the Effect of Sildenafil Citrate on Cerebral Blood Perfusion in Multiple Sclerosis Patients by Perfusion MRI|
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 subject's 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.
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 Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Multiple Sclerosis|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||May 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Any healthy normal volunteer above the age of 18 who is capable of giving informed consent recruited or self referred through the NIH Volunteer office will be eligible for this study.
All healthy normal volunteers will be included as long as there is no recorded or documented signs or symptoms of CNS disease, contraindications to a MRI and have a "normal age appropriate" MRI of the brain.
Patients seen in the Neuroimmunology MS clinic with a confirmed diagnosis of Multiple Sclerosis based upon previous history of two clinical neurological attacks separated in time and in spatial location or combination of Clinical and MRI findings of a single enhancing lesion in the brain or spine along with multiple T2 hyperintensities in the juxtacortical, periventricular or infratentorial white matter according to the McDonald criteria will be included in this study.
Relapsing-remitting or secondary progressive MS who have had more than one relapse within 18 months preceding study enrollment will be recruited from the MS 7th floor clinic in the NINDS at the NIH. MS patients will have EDSS score between 1.0 - 6.5, inclusive. MS patients seen and treated in the NINDS MS clinic are representative of the general MS population that is Female: male ratio of approximately 3:2, Caucasian and African American, between ages of 18-55 years old.
Give written informed consent prior to any testing under this protocol, including screening/pre-treatment tests and evaluations that are not considered part of the patient's routine care.
Healthy Controls and MS patients will be excluded if they have contraindications to MR scanning, such as the following:
Healthy controls and MS patients will be excluded from this study if they have the following:
MS patients will also be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:
Treatment History in MS patients
If prior treatment with steroids was received, the subject must have been off treatment for the required period prior to enrollment (see below).
Time Required off Agent Prior to Enrollment: 8 weeks
Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returning for follow-up visits to the NINDS, Neuroimmunology Clinic will be sufficient reason to exclude a subject.
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00094068|
|Other Study ID Numbers ICMJE||050003, 05-CC-0003|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2006|
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