Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Study ID
NCT01730131
Status
Recruiting
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Conditions

  • Progressive Multifocal Leukoencephalopathy

Eligibility Criteria

Sex
ALL
Age
2 Years - 120 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Nov 8, 2012
Status verified
May 2026
Primary completion
Jan 1, 2052

Study Design

Enrollment
700 participants (estimated)

Arms

  • Arm: Control Patients at Risk for PML
    Participants with impaired immune function from any cause and considered at risk for PML
  • Arm: Healthy Volunteers
    Healthy volunteers without impaired immune function
  • Arm: PML Patients
    Participants with PML

Primary Outcome Measure

To characterize the baseline presentation of patients with JCV infection and/or PML with regard to clinical, radiological, immunological, genetic and viral features. [ Time Frame: one year following last enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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