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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01582763
Registration number
NCT01582763
Ethics application status
Date submitted
20/04/2012
Date registered
23/04/2012
Date last updated
22/02/2023
Titles & IDs
Public title
International Guillain-Barré Syndrome Outcome Study
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Scientific 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).
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Secondary ID [1]
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0
3290
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Secondary ID [2]
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MEC-2011-477
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Universal Trial Number (UTN)
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Trial acronym
IGOS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Guillain-Barré Syndrome
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Miller Fisher Syndrome
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0
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Condition category
Condition code
Inflammatory and Immune System
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0
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Autoimmune diseases
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Neurological
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0
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0
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Other neurological disorders
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Other
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
GBS - Guillain-Barré syndrome >1000, follow-up 1-3 years
NC - Normal controls (NC)
IC - Infectious controls (IC)
OND - Other neurological diseases (OND)
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Guillain Barré Syndrome (GBS) disability score
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Assessment method [1]
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7 scores for disability, ranging from a healthy state to dead; 0 = healthy state to 6 = dead
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Timepoint [1]
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1 year
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Primary outcome [2]
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MRC sum score
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Assessment method [2]
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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
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Timepoint [2]
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1 year
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Secondary outcome [1]
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Overall Neuropathy Limitations Scale (ONLS)
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Assessment method [1]
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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
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Timepoint [1]
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1 year
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Secondary outcome [2]
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Fatigue Severity Scale (FSS)
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Assessment method [2]
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the FSS is a simple and reliable instrument to assess and quantify fatigue for clinical and research purposes.
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Timepoint [2]
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1 year
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Secondary outcome [3]
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EurQol EQ-5D Health Questionnaire
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Assessment method [3]
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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
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Timepoint [3]
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1 year
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Secondary outcome [4]
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Rasch-built Overall Disability Scale (R-ODS)
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Assessment method [4]
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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
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Timepoint [4]
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one year
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- There are no exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
2000
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [2]
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Concord Repatriation General Hospital Sydney - Sydney
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Recruitment postcode(s) [1]
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3050 - Parkville
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Recruitment postcode(s) [2]
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- Sydney
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Recruitment outside Australia
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Arizona
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Wakefield
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Funding & Sponsors
Primary sponsor type
Other
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Name
Erasmus Medical Center
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Address
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Ethics approval
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01582763
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bart Jacobs, Dr.
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Address
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Erasmus Medical Center
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01582763
Download to PDF