Learning about Progressive Multifocal Leukoencephalopathy
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Recruiting
Observational Study
Progressive Multifocal Leukoencephalopathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 – 120
Sex
Any
Study type
Observational
Participants needed
700 (estimated)
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) · NIH
Who this trial is looking for
This trial is looking for individuals diagnosed with Progressive Multifocal Leukoencephalopathy (PML) to help researchers understand the disease better. Participants will attend multiple visits for tests, including brain scans and sample collections over a year.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 2 years old
I have suspected or confirmed PML
I have an MRI compatible with PML
I can participate in the required studies
You may not be able to join if
I have a significant health condition that prevents me from participating
I cannot have an MRI due to medical reasons
I am pregnant
I cannot give informed consent
I am unwilling to allow biological samples to be collected
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 kn…
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.
Trial Locations
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City
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Status
Eligibility Criteria
* PML Patients
INCLUSION CRITERIA:
1. Suspected or confirmed PML
2. MRI compatible with PML
3. Able to participate in the studies and follow-up required by the protocol
4. At least 2 years old
EXCLUSION CRITERIA:
1. Significant condition, which in the judgment of the principal investigator, woul…
* PML Patients
INCLUSION CRITERIA:
1. Suspected or confirmed PML
2. MRI compatible with PML
3. Able to participate in the studies and follow-up required by the protocol
4. At least 2 years old
EXCLUSION CRITERIA:
1. Significant condition, which in the judgment of the principal investigator, would make participation in the diagnostic and research parts of evaluation impossible or risky
2. 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)
3. Pregnancy
4. Inability to provide informed consent, either directly or via legally authorized representative (LAR)
5. Unwillingness to consent for collection of biological samples or their cryopreservation
Control Patients at Risk for PML
INCLUSION CRITERIA:
1. Able to participate in the studies and follow-up required by the protocol
2. At least 2 years old
3. 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)
EXCLUSION CRITERIA:
1. Significant condition, which in the judgment of the principal investigator, would make participation in the diagnostic and research parts of evaluation impossible or risky
2. 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)
3. Pregnancy
4. Inability to provide informed consent, either directly or via legally authorized representative (LAR)
5. Unwillingness to consent for collection of biological samples or their cryopreservation
Healthy Volunteers
INCLUSION CRITERIA:
1. Able to participate in the studies and follow-up required by the protocol
2. At least 18 years old
EXCLUSION CRITERIA:
1. 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)
2. Significant condition, which in the judgment of the principal investigator, would make participation in the diagnostic and research parts of evaluation impossible or risky
3. 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)
4. Pregnancy
5. Inability to provide informed consent, either directly or via legally authorized representative (LAR)
6. Unwillingness to consent for collection of biological samples or their cryopreservation
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