Guillian-Barre syndrome MedDRA version: 19.0 Level: PT Classification code 10018767 Term: Guillain-Barre syndrome System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Nanogam
Pharmaceutical Form: Solution for infusion
CAS Number: 0
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration ty
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: diagnosed with GBS according to the international accepted criteria, given informed consent, patient in grade 3, 4 or 5 of the GBS disability scale or is there otherwise an indication for IVIg therapy according to the treating neurologist, less than two weeks since onset of weakness, able to attend follow-up of 6 months. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: age below 6 years, severe allergic reaction to properly matched blood products, known to have severe concurrent disease, having selective IgA deficiency, clinical evidence of polyneuropathy caused by other cause than GBS, received immune suppressive therapy during last month, pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether a second IVIg dosage in GBS patients with a poor prognosis improve functional outcome after 4 weeks.;Secondary Objective: -functional outcome or muscle strength after 8, 12 and 26 weeks. -the percentage of patients needing artificial ventilation, lower the time (number of days) on respirator or time on the intensive care. -reduces the time to hospital discharge. -reduce the chance of secondary deterioration due to treatment-related fluctuations (TRF†). -development of more complications possibly related to the second IVIg treatment. -lowers the percentage of patients that die because of GBS. -the serum IgG increase after the first IVIg dosage is lower in patients with a poor prognosis. -serum IgG increases further (and to what extent) after administration of a second IVIg dosage. ;Primary end point(s): Main study endpoint: GBS disability score at 4 weeks after start of first IVIg course. The full range of scores will be considered as an ordinal outcome scale. In analyzing we will use a proportional odds model. (Extent of) improvement on this ordinal scale will be compared between groups. Secondary study endpoints: -Percentage of patients that improve: at least 1, 2, 3 or 4 points on the GBS disability score at 4, 8, 12 and 26 weeks, at least 4, 8 or 12 points on MRC sum score (ranging from 0-60) at 4, 8, 12 and 26 weeks, at least 2, 4 or 6 points on ONLS score (ranging from 0-12) at 4, 8, 12 and 26 weeks. -Percentage of patients needing artificial ventilation. -Time (number of days) on respirator. -Time (number of days) on intensive care unit. -Percentage of patients that die because of GBS. -Time (number of days) to hospital discharge. -Percentage of patients with secondary deterioration due to treatment-related fluctuations (TRF). -Development of complications possibly related to a second IVIg course. -Serum IgG levels at 5 different time points. ;Timepoint(s) of evaluation of this end point: 1st of March 2018 | — |
Countries
Netherlands
Outcome results
None listed