International Guillain-Barré Syndrome Outcome Study

Guillain-Barré Syndrome Clinical Trial

— IGOS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01582763
• Other study ID #: MEC-2011-477
• Secondary ID: 3290
• Status: Active, not recruiting
• Start date: May 1, 2012
• Est. completion date: September 2024

Study information

• Verified date: February 2023
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: September 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Guillain-Barre Syndrome
• Guillain-Barré Syndrome
• Miller Fisher Syndrome
• Syndrome

Locations

Country	Name	City	State
Argentina	Hospital Austral	Buenos Aires
Argentina	Hospital Britanico	Buenos Aires
Argentina	Hospital Cesar Milstein	Buenos Aires
Argentina	Hospital de Clinicas	Buenos Aires
Argentina	Hospital Fleni	Buenos Aires
Argentina	Hospital Garrahan	Buenos Aires
Argentina	Hospital Militar	Buenos Aires
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Concord Repatriation General Hospital Sydney	Sydney
Bangladesh	Dhaka Medical College & Hospital	Dhaka
Bangladesh	ICDDR,B	Dhaka
Belgium	Clinique Universitaire St. Luc	Brussels
Belgium	University Hospital Leuven	Leuven
Canada	University of Calgary	Calgary
Canada	Queens University	Kingston
Canada	University hospital LHSC	London
Canada	University Health Network	Toronto
China	Xiang Hospital Central South University	Changsha	Hunan
China	Affiliated Hospital of Jining Medical University	Jining	Shandong
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	The affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
Denmark	Aalborg Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	National Hospital Copenhagen	Copenhagen
Denmark	Glostrup Hospital Copenhagen	Glostrup
Denmark	Odense University Hospital	Odense
France	Hospital de la Timone	Marseille
France	Nantes University Hospital	Nantes
France	Hôpital St. Louis de Paris	Paris
France	University Strassbourg	Strasbourg
Germany	Universitätsklinikum der RWTH	Aachen
Germany	University of Cologne	Cologne
Germany	Universitatsklinikum Dresden	Dresden
Germany	Heinrich Heine University	Duesseldorf
Germany	University Hospital of Saarland	Homburg
Germany	Universitatsklinikum Würzburg	Würzburg
Greece	University of Thessaly	Larissa	Thessaly
Italy	University of Genova	Genova
Italy	Ospedale Sant'Andrea La Spezia	la Spezia
Italy	Ospedale Luigi Sacco	Milan
Italy	Ospedale San Raffaele	Milan
Italy	University of Milan	Milan
Italy	University of Modena	Modena
Italy	University of Milano-Bicocca	Monza
Italy	Universita FedericoII di Napoli	Napoli
Italy	University of Padova	Padova
Italy	Policlinico Tor Vergata	Roma
Italy	Sant' Andrea Hospital	Rome
Japan	Chiba University School of Medicine	Chiba
Japan	Kinki University School of Medicine	Osaka
Japan	Hokkaido Medical Center	Sapporo
Japan	Dokkyo Medical Univeristy	Tochigi
Japan	National Defense Medical College	Tokorozawa
Japan	Toho University Medical Center	Tokyo
Malaysia	University of Malaya	Kuala Lumpur
Netherlands	AMC Amsterdam	Amsterdam
Netherlands	Gelre ziekenhuis	Apeldoorn
Netherlands	Rode Kruis Ziekenhuis	Beverwijk
Netherlands	Reinier de Graaf Groep	Delft
Netherlands	Jeroen Bosch Ziekenhuis	Den Bosch
Netherlands	HAGA ziekenhuis	Den Haag
Netherlands	MCH Westeinde	Den Haag
Netherlands	Van Weel-Bethesda Hospital	Dirksland
Netherlands	Albert Schweitzer Hospital	Dordrecht
Netherlands	Elkerliek hospital	Helmond
Netherlands	Westfriesgasthuis Hoorn	Hoorn
Netherlands	LUMC	Leiden
Netherlands	University Hospital Maastricht	Maastricht
Netherlands	CWZ Nijmegen	Nijmegen
Netherlands	Erasmus Medical Center	Rotterdam	Zuid Holland
Netherlands	Maasstad Hospital	Rotterdam
Netherlands	Sint Franciscus Gasthuis	Rotterdam
Netherlands	SSVZ	Schiedam
Netherlands	St. Elisabeth hospital	Tilburg
Puerto Rico	University of Puerto Rico	San Juan
South Africa	University of Cape Town	Cape Town
Spain	Hospital de Bellvitge	Barcelona
Spain	Hospital Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Clinica Hospital 2 de Octubre	Madrid
Spain	Hospital Universitario Infanta Sofia	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Complejo Hospitalario de Navarra	Pamplona
Spain	Hospital Marques de Valdecilla	Santander
Spain	Hospital de Santiago	Santiago De Compostela
Spain	Hospital Virgen de Sevilla	Sevilla
Switzerland	Universityhospital Bern, Inselspital	Bern
Switzerland	HFR - Cantonal Hospital	Fribourg
Switzerland	Hôpitaux Universitaires de Genève	Geneva
Switzerland	Lausanne University Hospital	Lausanne
Switzerland	Ospeale Civico Lugano	Lugano
Switzerland	Hopital du Valais	Sion
Switzerland	Kantonspital St. Gallen	St. Gallen
Taiwan	National Taiwan University Hospital	Tai Pei
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	University of Glasgow	Glasgow
United Kingdom	Hinching Brooke Hospital	Huntingdon
United Kingdom	NHS Forth Valley Hospital	Larbert
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	The Walton Centre	Liverpool
United Kingdom	Charing Cross Hospital	London
United Kingdom	King's College Hospital	London
United Kingdom	National Hospital of Neurology and Neurosurgery	London
United Kingdom	St. George's Hospital	London
United Kingdom	James Cook University Hospital	Middlesborough
United Kingdom	Royal Victoria Infirmary	Newcastle
United Kingdom	University of Oxford	Oxford
United Kingdom	Royal Hallamshire Hospital	Sheffield
United Kingdom	Pinderfields Hospital	Wakefield
United States	University of New Mexico	Albuquerque	New Mexico
United States	Johns Hopkins	Baltimore	Maryland
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Lahey clinic Boston	Boston	Massachusetts
United States	Tufts University School of Medicine	Boston	Massachusetts
United States	University at Buffalo	Buffalo	New York
United States	University of Vermont College of Medicine	Burlington	Vermont
United States	Northwestern University	Chicago	Illinois
United States	Wexner Medical Center at The Ohio State University	Columbus	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Spectrum Health System	Grand Rapids	Michigan
United States	The university of Texas Health Science Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	University of Florida	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Tennessee	Memphis	Tennessee
United States	University of Minnesota	Minneapolis	Minnesota
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Yale University School of medicine	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Montefiore MC	New York	New York
United States	Mt. Sinai School of Med	New York	New York
United States	UC Irvine Health	Orange	California
United States	Barrows Neurological Institute	Phoenix	Arizona
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	Southern Illinois University School of Medicine	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bangladesh,  Belgium,  Canada,  China,  Denmark,  France,  Germany,  Greece,  Italy,  Japan,  Malaysia,  Netherlands,  Puerto Rico,  South Africa,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Guillain Barré Syndrome (GBS) disability score	7 scores for disability, ranging from a healthy state to dead; 0 = healthy state to 6 = dead	1 year
Primary	MRC sum score	the sum of MRC scores of six muscle groups, including shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and foot dorsiflexors on both sides, ranging from 60 (normal) to 0 (quadriplegic). 0 = no visible contraction to 5 = normal strength, score per muscle group	1 year
Secondary	Overall Neuropathy Limitations Scale (ONLS)	Questions regarding affection of ability in both arms and legs, with a score from 0 = normal to 5 = disability in both arms preventing all purposeful movements and a score from 0 = walking/climbing stairs/running not affected to 7 = restricted to wheelchair or bed most of the day, unable to make any purposeful movements of the legs	1 year
Secondary	Fatigue Severity Scale (FSS)	the FSS is a simple and reliable instrument to assess and quantify fatigue for clinical and research purposes.	1 year
Secondary	EurQol EQ-5D Health Questionnaire	EQ-5D® is a standardized instrument for use as a measure of health outcome with a scale from 0 = the worst health you can imagine to 100 = the best health you can imagine	1 year
Secondary	Rasch-built Overall Disability Scale (R-ODS)	The R-ODS is a linearly weighted scale that specifically captures activity and social participation limitations in patients with GBS, CIDP, and MGUSP. Compared to the Overall Disability Sum Score, the R-ODS represents a wider range of item difficulties, thereby better targeting patients with different ability levels. If responsive, the R-ODS will be valuable for future clinical trials and follow-up studies in these conditions. Score from 0 = not possible to perform any activity to 48 = easy to perform any activity	one year

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