RecruitingNCT01730131

Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)


Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Enrollment

700 participants

Start Date

Nov 8, 2012

Study Type

OBSERVATIONAL

Conditions

Summary

Background: \- Progressive multifocal leukoencephalopathy (PML) is a severe viral infection of the brain. It is caused by JC virus. Many people have this virus in their bodies all their life, but it is usually kept in check by their immune system. If the immune system does not work right because of a disease or medication, the virus becomes active and can damage cells in the brain. Not much is known about PML or how it affects the immune system. Researchers want to study people with PML to better understand the natural history of the disease. Objectives: \- To study the natural history of PML. Eligibility: \- Individuals at least 2 years of age who have PML. Design: * Participants will be screened with a physical exam, medical history, and imaging studies. * Participants will have several visits to the National Institutes of Health Clinical Center. There will be an initial visit, monthly visits for the next 6 months, a 12-month visit, and possible visits afterward. * At the initial visit, participants will give blood, urine, and spinal fluid samples. They will also have neurological tests and imaging studies of the brain. * For the next five visits, participants will give blood and urine samples. They will also have neurological tests and imaging studies of the brain. * The 6-month and 12-month visits will repeat the tests from the initial visit. * Other optional procedures include bone marrow samples and skin biopsies. Additional blood tests and imaging studies may be performed. * Treatment will not be provided as part of this study.


Eligibility

Min Age: 2 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study follows people who have or are suspected to have a rare brain infection called Progressive Multifocal Leukoencephalopathy (PML) — a serious condition caused by a virus — to better understand its course and find better ways to diagnose and treat it. **You may be eligible if...** - You have been diagnosed with, or are suspected to have, PML - You have a brain MRI consistent with PML - You are at least 2 years old - You are able to participate in follow-up visits and tests **You may NOT be eligible if...** - You have a serious health condition that would make participation unsafe - You have a pacemaker or metal implants that prevent MRI - You are pregnant - You are unable to give consent yourself or through a legal representative - You are unwilling to allow blood and tissue samples to be collected and stored Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT01730131


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