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Guillain-Barré SyndromeIGOSNCT01582763

International Guillain-Barré Syndrome Outcome Study

An observational study of Guillain-Barré Syndrome and Miller Fisher Syndrome, run by Erasmus Medical Center at 138 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Any age
How many people
2,000 participants
Where
138 sitesin 21 countries
Study dates
1 May 2012to 2 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients with Guillain-Barré syndrome (GBS) or variants of GBS, including the Miller Fisher syndrome (MFS) and overlap syndromes.

Who may be able to join

  • 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 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

Who cannot join

  • There are no exclusion criteria

Trial locations and contacts

138 sites in 21 countries.

138 sites in 21 countries

United States26 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Johns Hopkins

    Baltimore, Maryland, 21205-1911

  • Lahey clinic Boston

    Boston, Massachusetts, 01805

  • Tufts University School of Medicine

    Boston, Massachusetts, 02135

  • University at Buffalo

    Buffalo, New York, 14203

  • University of Vermont College of Medicine

    Burlington, Vermont, 05405

  • Northwestern University

    Chicago, Illinois, 60611

  • Wexner Medical Center at The Ohio State University

    Columbus, Ohio, 43210

  • UT Southwestern

    Dallas, Texas, 75390

  • Spectrum Health System

    Grand Rapids, Michigan, 49525

  • The university of Texas Health Science Center

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242-1098

  • University of Florida

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7314

  • University of Tennessee

    Memphis, Tennessee, 38104

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Yale University School of medicine

    New Haven, Connecticut, 06520

  • Mt. Sinai School of Med

    New York, New York, 10029-6574

  • Columbia University

    New York, New York, 10032

  • Montefiore MC

    New York, New York, 10467

  • UC Irvine Health

    Orange, California, 92868

  • Barrows Neurological Institute

    Phoenix, Arizona, 85013

  • University of Utah School of Medicine

    Salt Lake City, Utah, 84132

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

Other trials in United States

Netherlands19 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • AMC Amsterdam

    Amsterdam

  • Gelre ziekenhuis

    Apeldoorn

  • Rode Kruis Ziekenhuis

    Beverwijk

  • Reinier de Graaf Groep

    Delft

  • Van Weel-Bethesda Hospital

    Dirksland

  • Albert Schweitzer Hospital

    Dordrecht

  • Elkerliek hospital

    Helmond

  • Westfriesgasthuis Hoorn

    Hoorn

  • LUMC

    Leiden

  • University Hospital Maastricht

    Maastricht

  • CWZ Nijmegen

    Nijmegen

  • Erasmus Medical Center

    Rotterdam, South Holland, 3000 CA

  • Maasstad Hospital

    Rotterdam

  • Sint Franciscus Gasthuis

    Rotterdam

  • SSVZ

    Schiedam

  • HAGA ziekenhuis

    The Hague

  • MCH Westeinde

    The Hague

  • St. Elisabeth hospital

    Tilburg

Other trials in Netherlands

United Kingdom18 sites

  • Queen Elizabeth Hospital

    Birmingham

  • Bradford Royal Infirmary

    Bradford

  • Addenbrooke's Hospital

    Cambridge

  • Western General Hospital

    Edinburgh

  • University of Glasgow

    Glasgow

  • Hinching Brooke Hospital

    Huntingdon

  • NHS Forth Valley Hospital

    Larbert

  • Leeds General Infirmary

    Leeds

  • The Walton Centre

    Liverpool

  • Charing Cross Hospital

    London

  • King's College Hospital

    London

  • National Hospital of Neurology and Neurosurgery

    London

  • St. George's Hospital

    London

  • James Cook University Hospital

    Middlesbrough

  • Royal Victoria Infirmary

    Newcastle

  • University of Oxford

    Oxford

  • Royal Hallamshire Hospital

    Sheffield

  • Pinderfields Hospital

    Wakefield

Other trials in United Kingdom

Italy11 sites

  • University of Genova

    Genova

  • Ospedale Sant'Andrea La Spezia

    La Spezia

  • Ospedale Luigi Sacco

    Milan

  • Ospedale San Raffaele

    Milan

  • University of Milan

    Milan

  • University of Modena

    Modena

  • University of Milano-Bicocca

    Monza

  • Universita FedericoII di Napoli

    Naples

  • University of Padova

    Padova

  • Policlinico Tor Vergata

    Roma

  • Sant' Andrea Hospital

    Rome

Other trials in Italy

Spain10 sites

  • Hospital de Bellvitge

    Barcelona

  • Hospital Santa Creu I Sant Pau

    Barcelona

  • Hospital Universitario Reina Sofia

    Córdoba

  • Clinica Hospital 2 de Octubre

    Madrid

  • Hospital Universitario Infanta Sofia

    Madrid

  • Hospital Universitario Central de Asturias

    Oviedo

  • Complejo Hospitalario de Navarra

    Pamplona

  • Hospital Marques de Valdecilla

    Santander

  • Hospital de Santiago

    Santiago de Compostela

  • Hospital Virgen de Sevilla

    Seville

Other trials in Spain

Argentina7 sites

  • Hospital Austral

    Buenos Aires

  • Hospital Britanico

    Buenos Aires

  • Hospital Cesar Milstein

    Buenos Aires

  • Hospital de Clinicas

    Buenos Aires

  • Hospital Fleni

    Buenos Aires

  • Hospital Garrahan

    Buenos Aires

  • Hospital Militar

    Buenos Aires

Other trials in Argentina

Switzerland7 sites

  • Universityhospital Bern, Inselspital

    Bern, 3010

  • HFR - Cantonal Hospital

    Fribourg, 1708

  • Hôpitaux Universitaires de Genève

    Geneva, 1205

  • Lausanne University Hospital

    Lausanne, 1011

  • Ospeale Civico Lugano

    Lugano, 6900

  • Kantonspital St. Gallen

    Sankt Gallen, 9007

  • Hopital du Valais

    Sion

Other trials in Switzerland

Germany6 sites

  • Universitätsklinikum der RWTH

    Aachen

  • University of Cologne

    Cologne

  • Universitatsklinikum Dresden

    Dresden

  • Heinrich Heine University

    Düsseldorf

  • University Hospital of Saarland

    Homburg

  • Universitatsklinikum Würzburg

    Würzburg

Other trials in Germany

Japan6 sites

  • Chiba University School of Medicine

    Chiba

  • Kinki University School of Medicine

    Osaka

  • Hokkaido Medical Center

    Sapporo

  • Dokkyo Medical Univeristy

    Tochigi

  • National Defense Medical College

    Tokorozawa

  • Toho University Medical Center

    Tokyo

Other trials in Japan

Denmark5 sites

  • Aalborg Hospital

    Aalborg

  • Aarhus University Hospital

    Aarhus

  • National Hospital Copenhagen

    Copenhagen

  • Glostrup Hospital Copenhagen

    Glostrup Municipality

  • Odense University Hospital

    Odense

Other trials in Denmark

Canada4 sites

  • University of Calgary

    Calgary

  • Queens University

    Kingston

  • University hospital LHSC

    London

  • University Health Network

    Toronto

Other trials in Canada

China4 sites

  • Xiang Hospital Central South University

    Changsha, Hunan, 410000

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272001

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • The affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

Other trials in China

France4 sites

  • Hospital de la Timone

    Marseille

  • Nantes University Hospital

    Nantes

  • Hôpital St. Louis de Paris

    Paris, Paris, 75016

  • University Strassbourg

    Strasbourg

Other trials in France

Australia2 sites

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Concord Repatriation General Hospital Sydney

    Sydney

Other trials in Australia

Bangladesh2 sites

  • Dhaka Medical College & Hospital

    Dhaka

  • ICDDR,B

    Dhaka

Other trials in Bangladesh

Belgium2 sites

  • Clinique Universitaire St. Luc

    Brussels

  • University Hospital Leuven

    Leuven

Other trials in Belgium

Greece1 site

  • University of Thessaly

    Larissa, Thessaly

Other trials in Greece

Malaysia1 site

  • University of Malaya

    Kuala Lumpur

Other trials in Malaysia

Puerto Rico1 site

  • University of Puerto Rico

    San Juan

Other trials in Puerto Rico

South Africa1 site

  • University of Cape Town

    Cape Town

Other trials in South Africa

Taiwan1 site

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

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).

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.

Read the detailed 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.

Keywords
Guillain-Barré syndrome, Polyneuropathy, Autoimmune Diseases, Immune System Diseases, Neuromuscular Diseases, Outcome, Quality of life, Disability, Prognostic Determinants, Treatment, Immunoglobulins, Prognosis, Infections, Anti-ganglioside antibodies, Genetic polymorphisms, Electrophysiology, Cerebrospinal Fluid, Serum
Medical subject headings
Guillain-Barre Syndrome, Miller Fisher Syndrome, Polyneuropathies, Autoimmune Diseases, Immune System Diseases, Neuromuscular Diseases, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01582763
Study groupRoleWhat they receive
GBSGuillain-Barré syndrome >1000, follow-up 1-3 years
NCNormal controls (NC)
ICInfectious controls (IC)
ONDOther neurological diseases (OND)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Guillain Barré Syndrome (GBS) disability score

    7 scores for disability, ranging from a healthy state to dead; 0 = healthy state to 6 = dead

    Measured: 1 year

  2. 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

    Measured: 1 year

Secondary outcomes (4)

  1. 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

    Measured: 1 year

  2. Fatigue Severity Scale (FSS)

    the FSS is a simple and reliable instrument to assess and quantify fatigue for clinical and research purposes.

    Measured: 1 year

  3. 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

    Measured: 1 year

  4. 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

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2012 (estimated)
  2. Study start1 May 2012
  3. Primary completion1 Sep 2024
  4. Study completion2 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01582763
Sponsor's protocol ID
MEC-2011-477
Other IDs
3290
Acronym
IGOS
Status last verified
Dec 2024
First submitted
20 Apr 2012
Last updated
12 Dec 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Doets AY, Lingsma HF, Walgaard C, Islam B, Papri N, Davidson A, Yamagishi Y, Kusunoki S, Dimachkie MM, Waheed W, Kolb N, Islam Z, Mohammad QD, Harbo T, Sindrup SH, Chavada G, Willison HJ, Casasnovas C, Bateman K, Miller JAL, van den Berg B, Verboon C, Roodbol J, Leonhard SE, Benedetti L, Kuwabara S, Van den Bergh P, Monges S, Marfia GA, Shahrizaila N, Galassi G, Pereon Y, Burmann J, Kuitwaard K, Kleyweg RP, Marchesoni C, Sedano Tous MJ, Querol L, Illa I, Wang Y, Nobile-Orazio E, Rinaldi S, Schenone A, Pardo J, Vermeij FH, Lehmann HC, Granit V, Cavaletti G, Gutierrez-Gutierrez G, Barroso FA, Visser LH, Katzberg HD, Dardiotis E, Attarian S, van der Kooi AJ, Eftimov F, Wirtz PW, Samijn JPA, Gilhuis HJ, Hadden RDM, Holt JKL, Sheikh KA, Karafiath S, Vytopil M, Antonini G, Feasby TE, Faber CG, Gijsbers CJ, Busby M, Roberts RC, Silvestri NJ, Fazio R, van Dijk GW, Garssen MPJ, Straathof CSM, Gorson KC, Jacobs BC; IGOS Consortium. Predicting Outcome in Guillain-Barre Syndrome: International Validation of the Modified Erasmus GBS Outcome Score. Neurology. 2022 Feb 1;98(5):e518-e532. doi: 10.1212/WNL.0000000000013139. Epub 2021 Dec 22.

    PubMed 34937789

  • Jacobs BC, van den Berg B, Verboon C, Chavada G, Cornblath DR, Gorson KC, Harbo T, Hartung HP, Hughes RAC, Kusunoki S, van Doorn PA, Willison HJ; IGOS Consortium. International Guillain-Barre Syndrome Outcome Study: protocol of a prospective observational cohort study on clinical and biological predictors of disease course and outcome in Guillain-Barre syndrome. J Peripher Nerv Syst. 2017 Jun;22(2):68-76. doi: 10.1111/jns.12209.

    PubMed 28406555

Questions about this trial

What is this clinical trial studying?

An observational study of Guillain-Barré Syndrome and Miller Fisher Syndrome, run by Erasmus Medical Center at 138 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Netherlands, United Kingdom, Italy, Spain and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Guillain Barré Syndrome (GBS) disability score (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01582763, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.

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