International Guillain-Barré Syndrome Outcome Study (IGOS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01582763|
Recruitment Status : Recruiting
First Posted : April 23, 2012
Last Update Posted : January 5, 2017
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.
|Condition or disease|
|Guillain-Barré Syndrome Miller Fisher Syndrome|
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.
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|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).|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||January 2019|
Guillain-Barré syndrome >1000, follow-up 1-3 years
Normal controls (NC)
Infectious controls (IC)
Other neurological diseases (OND)
- Guillain-Barre Syndrome(GBS) disability score and Medical Research Council(MRC) sumscore [ Time Frame: 1 year ]
- Overall Neuropathy Limitations Scale (ONLS) [ Time Frame: 1 year ]
- Fatigue Severity Scale (FSS) [ Time Frame: 1 year ]
- EurQol EQ-5D Health Questionnaire [ Time Frame: 1 year ]
- Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: one year ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582763
|Contact: Bianca van den Berg, Drs, MDemail@example.com|
|Contact: Bart C Jacobs, MD, DR, PHDfirstname.lastname@example.org|
Show 128 Study Locations
|Principal Investigator:||Bart Jacobs, Dr.||Erasmus Medical Center|