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NCT01730131 · ClinicalTrials.gov registry record
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
A clinical trial of Progressive Multifocal Leukoencephalopathy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Recruiting
- Registry status
- 700
- Enrollment target
- 1
- Study location
NCT01730131: Recruiting study of Progressive Multifocal Leukoencephalopathy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT01730131 is a study of Progressive Multifocal Leukoencephalopathy that is actively recruiting participants, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 700 participants, above the 26-participant average among 3 other Progressive Multifocal Leukoencephalopathy trials with a reported enrollment target (2592% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01730131, a study of Progressive Multifocal Leukoencephalopathy, is actively recruiting participants, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- RECRUITING
- Registry status
- 700 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
1\. Characterization of distinctive imaging features to differentiate between actively progressing PML, PML-IRIS/inflammatory PML and inactive PML2. Characterization of distinctive clinical features to differentiate between actively progressing PML, PML-IRIS/inflammatory PML, and inactive PML3. Characterization of immune and virological features to differentiate between actively progressing PML, PML-IRIS/inflammatory PML, and inactive PML4. Characterization of immune and virological differences
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2012-11-08 |
What NCT01730131 shows while recruiting
NCT01730131 is an observational study that tracks outcomes without assigning an intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, above the 26-participant average among 3 other Progressive Multifocal Leukoencephalopathy trials with a reported enrollment target (2592% higher).
The record links to 1 condition, with Progressive Multifocal Leukoencephalopathy appearing as the primary indexed condition, and to 0 interventions.
NCT01730131 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01730131 about?
NCT01730131 is a clinical study titled "Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)". 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...
What is the current status of trial NCT01730131?
This trial is currently recruiting. The enrollment target is 700 participants. The study started on 2012-11-08.
What conditions does trial NCT01730131 study?
This clinical trial studies the following conditions: Progressive Multifocal Leukoencephalopathy.
Who is sponsoring clinical trial NCT01730131?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01730131 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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