A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome (NCT04752566) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome
Japan57 participantsStarted 2021-03-08
Plain-language summary
This is a Phase 3, prospective, multicenter, placebo controlled, double blind, randomized study to investigate the efficacy and safety of eculizumab in participants with severe GBS, defined using the Hughes Functional Grade (FG) scale as progressively deteriorating FG3 or FG4/FG5 within 2 weeks from onset of weakness due to GBS.
This study will be conducted only at sites in Japan.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants who meet the GBS criteria.
* Participants who were able to run prior to onset of GBS symptoms.
* Participants with onset of weakness due to GBS \< 2 weeks before screening.
* Participants unable to walk unaided for ≥ 5 meters (progressively deteriorating FG3 or FG4 to FG5).
* Participants who are already on IVIg or deemed eligible for and who will start IVIg.
* Participants who can start their first dose of study drug before the end of the IVIg treatment period.
Exclusion Criteria:
* Participants who have previously received or are currently receiving treatment with complement modulators.
* Participants who have been administered another investigational product within 30 days or 5 half-lives (whichever is longer) prior to providing consent or are currently participating in another interventional study.
* Participants who have received rituximab within 12 weeks prior to screening.
* Participants who are being considered for or are already on plasmapheresis.
* Participants who have received immunosuppressive treatment during the 4 weeks prior to providing consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to First Reaching a Hughes Functional Grade (FG) Score <=1