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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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).
Secondary ID [1] 0 0
3290
Secondary ID [2] 0 0
MEC-2011-477
Universal Trial Number (UTN)
Trial acronym
IGOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Guillain-Barré Syndrome 0 0
Miller Fisher Syndrome 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Neurological 0 0 0 0
Other neurological disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Guillain Barré Syndrome (GBS) disability score
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
MRC sum score
Timepoint [2] 0 0
1 year
Secondary outcome [1] 0 0
Overall Neuropathy Limitations Scale (ONLS)
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Fatigue Severity Scale (FSS)
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
EurQol EQ-5D Health Questionnaire
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Rasch-built Overall Disability Scale (R-ODS)
Timepoint [4] 0 0
one year

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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* There are no exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
Accrual to date
Final
2000
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital Sydney - Sydney
Recruitment postcode(s) [1] 0 0
3050 - Parkville
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
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Wakefield

Funding & Sponsors
Primary sponsor type
Other
Name
Erasmus Medical Center
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01582763
Trial related presentations / 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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bart Jacobs, Dr.
Address 0 0
Erasmus Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01582763