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Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Progressive Multifocal Leukoencephalopathy

Phase: N/A

Status: Terminated

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen


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).

Clinical Details

Official title: Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

Study design: Observational Model: Case-Only, Time Perspective: Cross-Sectional

Primary outcome: to examine host genetic variation and possible genetic susceptibility to PML

Secondary outcome:

To explore predisposing factors of the innate and adaptive immune system

To analyze DNA sequences of JCV

optional substudy: to test alterations in DNA repair pathways

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Key Inclusion Criteria:

- Subjects who have confirmed PML while on treatment with Natalizumab

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Locations and Contacts

Research Site, Wuerzburg, Germany

North Central Neurology Associates, Cullman, Alabama 35058, United States

Rocky Mountain MS Center at Anschutz Medical Campus University Colorado Denver, Aurora, Colorado 80045, United States

Rush Medical Center - Rush Multiple Sclerosis Center, Chicago, Illinois 60612, United States

St. Vincent Hospital, St. Vincent Neuroscience Institute, Indianapolis, Indiana 46260, United States

Central Neurology, Hastings, Nebraska 68901, United States

Clinical Research Center UH, The Nebraska Medical Center, Omaha, Nebraska 68105, United States

NYU Hospital for Joint Disease, MS Care Center, New York, New York 10003, United States

University of Rochester, Rochester, New York 14642, United States

Research Site, Cincinnati, Ohio 45208, United States

Neurology of Bend, LLC, Bend, Oregon 97701, United States

Additional Information

Starting date: October 2010
Last updated: January 15, 2015

Page last updated: August 23, 2015

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