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Protocol Details

Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-N-0017

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Immune Reconstitution Syndrome;
Human Immunodeficiency Virus;
Multiple Sclerosis

Recruitment Keyword(s)

None

Condition(s)

Progressive Multifocal Leukoencephalopathy

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

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 appointed power of attorney

5. Unwillingness to consent for collection of biological samples or their cryopreservation


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Citations:

Cinque P, Koralnik IJ, Gerevini S, Miro JM, Price RW. Progressive multifocal leukoencephalopathy in HIV-1 infection. Lancet Infect Dis. 2009 Oct;9(10):625-36. doi: 10.1016/S1473-3099(09)70226-9.

Padgett BL, Walker DL, ZuRhein GM, Eckroade RJ, Dessel BH. Cultivation of papova-like virus from human brain with progressive multifocal leucoencephalopathy. Lancet. 1971 Jun 19;1(7712):1257-60.

Gheuens S, Pierone G, Peeters P, Koralnik IJ. Progressive multifocal leukoencephalopathy in individuals with minimal or occult immunosuppression. J Neurol Neurosurg Psychiatry. 2010 Mar;81(3):247-54. doi: 10.1136/jnnp.2009.187666. Epub 2009 Oct 14.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Avindra Nath, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7C103
10 CENTER DR
BETHESDA MD 20814
(301) 496-1561
natha@mail.nih.gov

Avindra Nath, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7C103
10 CENTER DR
BETHESDA MD 20814
(301) 496-1561
natha@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01730131

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