International Guillain-Barré Syndrome Outcome Study



Status:Recruiting
Healthy:No
Age Range:Any
Updated:1/6/2017
Start Date:May 2012
End Date:January 2019
Contact:Bianca van den Berg, Drs, MD
Email:gbsstudies@erasmusmc.nl
Phone:0031107042209

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International GBS Outcome Study (IGOS): A Prospective INC Study on Clinical and Biological Predictors of Disease Course and Outcome in Guillain-Barré Syndrome (GBS).

International GBS Outcome Study (IGOS) is a study conducted by the members of the
Inflammatory Neuropathy Consortium (INC) and Peripheral Nerve Society (PNS) on disease
course and outcome in Guillain-Barré syndrome (GBS).

The IGOS aims to identify clinical and biological determinants and predictors of disease
course and outcome in individual patients with Guillain-Barré syndrome, as early as possible
after onset of disease.

GBS is a post-infectious immune-mediated polyradiculoneuropathy with a highly diverse
clinical course and outcome despite partially effective forms of treatment(immunoglobulins
and plasma exchange). Outcome in patients with GBS has not improved in the last two decades.
At present about 10 to 20% of patients remain severely disabled and about 5% die. One
explanation for this stagnation is the highly variable clinical course of GBS and the lack
of knowledge about the factors that determine the clinical course in individual patients
with GBS. GBS may consist of distinct pathogenic subgroups, in which disease onset and
progression is influenced by different types of preceding infections, anti-neural antibodies
and genetic polymorphisms. Optimal treatment of individual patients may depend on the
pathogenesis and clinical severity. Patients with severe forms of GBS may possibly need more
intensive treatment to recover. Patients with a milder course that fully recover after
standard therapy could suffer from possibly more side effects of more aggressive forms of
treatment. This could only be possible if there are prognostic models that accurately
predict the clinical course in individual patients. Ideally such models should be based on
clinical and biological predictors that are strongly associated with disease course and
known as early as possible in the acute phase of illness, when treatment with
immunomodulatory therapy is most effective. Prognostic models could help to guide selective
trials in specific GBS subtypes. Because of this it will be possible to treat GBS with more
effective and more individual therapy.

This study aims to identify clinical and biological determinants and predictors of disease
course and outcome in individual patients with Guillain-Barré syndrome, as early as possible
after onset of disease. This information will be used to understand the diversity in
clinical presentation and response to treatment of GBS. This information will also be used
to develop new prognostic models to predict the clinical course and outcome accurately in
individual patients with GBS.

To address these research questions it is required to conduct a prospective study with
standardized collection of clinical data and biomaterials from a large group of well-defined
GBS patients during a long follow-up period. Such an extensive study in a relatively rare
disease as GBS can be addressed only by intensive international collaboration.

Inclusion Criteria:

- Fulfil diagnostic criteria for GBS of National Institute of Neurological Disorders
and Stroke (NINDS). Patients with Miller Fisher syndrome and all other variants of
GBS, including overlap syndromes, can be included.

- Inclusion of all males and females of all ages, independent of disease severity and
treatment

- Inclusion within two weeks of onset of weakness

- Inclusion of patients transferred from another hospital if the stay in the first
hospital was less than one week

- Opportunity to conduct a follow-up of at least one year

- Informed consent of patient or, in case of children, of parents or legal guardians

Exclusion Criteria:

- There are no exclusion criteria
We found this trial at
27
sites
Grand Rapids, Michigan 49503
Principal Investigator: Paul Twydell
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Grand Rapids, MI
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
Principal Investigator: Waheed Waqar
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Burlington, VT
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Jeri Sieren
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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920 Madison Ave
Memphis, Tennessee 38163
Principal Investigator: Tulio Bertorini
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Memphis, TN
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Gregg Meekins
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Christopher Calder
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Albuquerque, NM
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655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
Principal Investigator: Justin Kwan, MD
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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Baltimore, MD
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Baltimore, Maryland 21218
(410) 516-8000
Principal Investigator: Mohammed Khoshnoodi
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
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Baltimore, MD
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Boston, Massachusetts
Principal Investigator: Michal Vytopil
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Boston, MA
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Boston, Massachusetts 02111
Principal Investigator: Ken Gorson, Dr
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Boston, MA
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Buenos Aires,
Principal Investigator: Andres Berardo
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Buenos Aires,
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Buffalo, New York 14215
Principal Investigator: Nicholas Silvestri
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Buffalo, NY
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Senda Ajroud-Driss
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Chicago, IL
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Columbus, Ohio 43210
Principal Investigator: Amro Stino
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Columbus, OH
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Dallas, Texas 75390
Principal Investigator: Diana Castro
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Dallas, TX
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Houston, Texas 77030
Principal Investigator: Kazim Sheikh
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Houston, TX
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Jacksonville, Florida 32209
Principal Investigator: Michael Pulley
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Jacksonville, FL
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Kansas, Kansas
Principal Investigator: Mazen Dimachkie
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Kansas, KS
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New Brunswick, New Jersey 08901
Principal Investigator: Shan Chen
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New Brunswick, NJ
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Richard Nowak
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Haven, CT
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New York, New York
Principal Investigator: Volkan Granit
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New York, NY
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New York, New York
Principal Investigator: Lan Zhou
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New York City, New York 10032
Principal Investigator: Tom Brannagan
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Orange, California
Principal Investigator: Namita Goyal
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Orange, CA
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Phoenix, Arizona 85013
Principal Investigator: Shafeeq Ladha
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Phoenix, AZ
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Salt Lake City, Utah 84132
Principal Investigator: Summer Karafiath
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Salt Lake City, UT
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801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Principal Investigator: James Gilchrist
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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Springfield, IL
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