International Guillain-Barré Syndrome Outcome Study (IGOS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Erasmus Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. B.C. Jacobs, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01582763
First received: April 20, 2012
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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
Guillain-Barré Syndrome
Miller Fisher Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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).

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • Guillain-Barre Syndrome(GBS) disability score and Medical Research Council(MRC) sumscore [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Neuropathy Limitations Scale (ONLS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Fatigue Severity Scale (FSS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • EurQol EQ-5D Health Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum, cerebrospinal fluid, samples with DNA


Estimated Enrollment: 4000
Study Start Date: May 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
GBS
Guillain-Barré syndrome >1000, follow-up 1-3 years
NC
Normal controls (NC)
IC
Infectious controls (IC)
OND
Other neurological diseases (OND)

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582763

Contacts
Contact: Bianca van den Berg, Drs, MD 0031107042209 b.vandenberg.2@erasmusmc.nl
Contact: Bart C Jacobs, MD, DR, PHD 0031107043999 b.jacobs@erasmusmc.nl

  Show 121 Study Locations
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: Bart Jacobs, Dr. Erasmus Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. B.C. Jacobs, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01582763     History of Changes
Other Study ID Numbers: MEC-2011-477, 3290
Study First Received: April 20, 2012
Last Updated: November 26, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
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

Additional relevant MeSH terms:
Cerebellar Diseases
Guillain-Barre Syndrome
Miller Fisher Syndrome
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 01, 2014