Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

NCT ID: NCT01211639

Last Updated: 2015-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-08-31

Brief Summary

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The purpose of this study is to explore host genetic mutations which may render individual subjects more susceptible (or resistant) to developing Progressive Multifocal Leukoencephalopathy (PML). Samples will also be collected to determine Deoxyribonucleic Acid (DNA) sequence of JC Virus (JCV). Analysis of the JC Virus (JCV) genome may provide information about viral genotypes that may be associated with higher pathogenicity, and help to identify individuals who may be at higher risk of developing Progressive Multifocal Leukoencephalopathy (PML) due to chronic infection with a more pathogenic variant of JC Virus (JCV).

Detailed Description

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Deoxyribonucleic acid (DNA) will be analyzed from natalizumab-treated subjects who develop Progressive Multifocal Leukoencephalopathy (PML). The genetic analysis of the subjects will directly seek mutations that could identify subjects at risk.

Conditions

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Progressive Multifocal Leukoencephalopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Subjects who have confirmed PML while on treatment with Natalizumab
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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North Central Neurology Associates

Cullman, Alabama, United States

Site Status

Rocky Mountain MS Center at Anschutz Medical Campus University Colorado Denver

Aurora, Colorado, United States

Site Status

Rush Medical Center - Rush Multiple Sclerosis Center

Chicago, Illinois, United States

Site Status

St. Vincent Hospital, St. Vincent Neuroscience Institute

Indianapolis, Indiana, United States

Site Status

Central Neurology

Hastings, Nebraska, United States

Site Status

Clinical Research Center UH, The Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

NYU Hospital for Joint Disease, MS Care Center

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Research Site

Cincinnati, Ohio, United States

Site Status

Neurology of Bend, LLC

Bend, Oregon, United States

Site Status

Research Site

Würzburg, , Germany

Site Status

Countries

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United States Germany

Other Identifiers

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101JC403

Identifier Type: -

Identifier Source: org_study_id

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