NCT01730131Recruiting
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 700 (estimated)
- First submitted
- 17 Nov 2012
- Start date
- 8 Nov 2012
- Primary completion date
- 1 Jan 2052
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Diseases
- HIV, Multiple sclerosis
- NCT number
- NCT01730131
What you commit to
- Study type: Observational
- Planned participants: 700
- From 8 Nov 2012 to the primary completion date, 1 Jan 2052
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Impaired immune function (i.e.-history of hematological malignancy, chronic inflammatory disease, history of treatment with immune suppressive or immunomodulatory therapies, primary or acquired immunodeficiency syndromes)
Other illness
- Significant condition, which in the judgment of the principal investigator, would make participation in the diagnostic and research parts of evaluation impossible or risky
- Medical contraindication to MRI (i.e., devices such as a cardiac pacemaker or infusion pump, other metallic implants, metallic foreign objects, body piercings that cannot be removed)
- Significant condition, which in the judgment of the principal investigator, would make participation in the diagnostic and research parts of evaluation impossible or risky
- Medical contraindication to MRI (i.e., devices such as a cardiac pacemaker or infusion pump, other metallic implants, metallic foreign objects, body piercings that cannot be removed)
- Significant condition, which in the judgment of the principal investigator, would make participation in the diagnostic and research parts of evaluation impossible or risky
- Medical contraindication to MRI (i.e., devices such as a cardiac pacemaker or infusion pump, other metallic implants, metallic foreign objects, body piercings that cannot be removed)
Other
- Pregnancy
- Inability to provide informed consent, either directly or via legally authorized representative (LAR)
- Unwillingness to consent for collection of biological samples or their cryopreservation
- Control Patients at Risk for PML
- Pregnancy
- Inability to provide informed consent, either directly or via legally authorized representative (LAR)
- Unwillingness to consent for collection of biological samples or their cryopreservation
- Healthy Volunteers
- Pregnancy
- Inability to provide informed consent, either directly or via legally authorized representative (LAR)
- Unwillingness to consent for collection of biological samples or their cryopreservation
Who the study is looking for
- Suspected or confirmed PML
- MRI compatible with PML
- Able to participate in the studies and follow-up required by the protocol
- At least 2 years old
- Able to participate in the studies and follow-up required by the protocol
- At least 2 years old
- Impaired immune function from any cause and considered at risk for PML (i.e.-history of hematological malignancy, chronic inflammatory disease, history of treatment with immune suppressive or immunomodulatory therapies, primary or acquired immunodeficiency syndromes)
- Able to participate in the studies and follow-up required by the protocol
- At least 18 years old
Criteria the registry did not label
- PML Patients
Age in the registry: 2 years to 120 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.