ICA-GBS

Phase 1

• Conditions: Guillain-Barré Syndrome; MedDRA version: 14.1Level: LLTClassification code 10018766Term: Guillain Barre syndromeSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-000228-33-GB
• Lead Sponsor: HS Greater Glasgow & Clyde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-01
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Patients aged =18 years diagnosed with GBS according to NINDS diagnostic criteria
•Onset of weakness due to GBS is less than 2 weeks ago
•Patients who are unable to walk unaided for >10 meters
(grade = 3 on GBS disability scale)
•Patients who are being considered for or already on IVIg treatment
•First dose of eculizumab must be started within 2 weeks from onset of weakness and any
time during the IVIg treatment period
•Signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Age<18 years

•Patients who are being considered for, or already on, plasma exchange

•Pregnancy or lactation

•Patient shows clear clinical evidence of a polyneuropathy caused by e.g. diabetes mellitus
(except mild sensory), alcoholism, severe vitamin deficiency, and porphyria

•Patient received immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycofenolatemofetil,
tacrolimus, sirolimus or > 20 mg prednisolone daily) during the last month

•Patient known to have a severe concurrent disease, like malignancy, severe cardiovascular disease, AIDS,
severe COPD, TB

•Inability to comply with study related procedures or appointments during 6 months

•Any condition that in the opinion of the investigator could increase the patient’s risk by participating in the
study or confound the outcome of the study

•Related to the administration of eculizumab:

?Unresolved Neisseria meningitidis infection or history of meningococcal infection
?Unsuitable for antibiotic prophylaxis (e.g. due to allergy)
?Known hypersensitivity to eculizumab, murine proteins or to any of the excipients
?Known or suspected hereditary complement deficiencies
?Women of child-bearing potential who are unwilling to use effective contraception during treatment and for 5
months after treatment is completed.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate safety and tolerability, of eculizumab in patients with GBS.;Secondary Objective: To determine whether more GBS patients improve in functional outcome (GBS disability scale) after treatment with eculizumab and IVIg compared to placebo controls, 4 weeks after randomisation.;Primary end point(s): Primary safety endpoint<br>To determine the incidence of AE/SAEs after treatment with eculizumab and IVIg compared to placebo controls<br><br>Primary Efficacy Endpoint<br>Improvement of one or more grade in functional outcome (on the 6 point GBS disability scale) at 4 weeks.<br>;Timepoint(s) of evaluation of this end point: Primary Safety endpoint timepoint will be at close of study.<br><br>Primary Efficacy Endpoint will be evaluated by the research team at 4 weeks.