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The Effect of Sildenafil Citrate (Viagra® (Registered Trademark)) on Brain Blood Flow in Multiple Sclerosis Patients

NCT00094068 · View on ClinicalTrials.gov ↗

Study 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 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.

Conditions Studied

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center (CC) — Bethesda

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2004-10
Est. Completion 2006-05

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00094068

The ClinicalTrials.gov registry entry for NCT00094068 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 209 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00094068 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00094068 about?

NCT00094068 is a clinical study titled "The Effect of Sildenafil Citrate (Viagra® (Registered Trademark)) on Brain Blood Flow in Multiple Sclerosis Patients". 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 be...

What is the current status of trial NCT00094068?

This trial is currently completed. The enrollment target is 76 participants. The study started on 2004-10. Estimated completion is 2006-05.

What conditions does trial NCT00094068 study?

This clinical trial studies the following conditions: Multiple Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT00094068?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 209 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00094068 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial