A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome
Study Identifier:
ECU-GBS-301
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Available Documents
Study Details
Medical Condition
- Guillain-Barre Syndrome
Study Drug
- Biological: Eculizumab
- Drug: Placebo
Date
Mar 2021 - Aug 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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.
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Guillain-Barre Syndrome
Study Drug
- Biological: Eculizumab
- Drug: Placebo
Date
Mar 2021 - Aug 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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.
Protocol 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.
Trial Locations
Location
Status
Location
Research Site
Bunkyō City, Japan, 113-8519
Status
N/A
Location
Research Site
Chiba, Japan, 260-0877
Status
N/A
Location
Research Site
Fukuoka, Japan, 814-0180
Status
N/A
Location
Research Site
Hiroshima, Japan, 730-8518
Status
N/A
Location
Research Site
Kagoshima, Japan, 890-8520
Status
N/A
Location
Research Site
Kawagoe-shi, Japan, 350-8550
Status
N/A
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