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
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Unmapped
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
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Unmapped
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
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
Clinical Trial Site
Bunkyo-ku, Japan, 113-8519
Status
N/A
Location
Clinical Trial Site
Chiba, Japan, 260-8677
Status
N/A
Location
Clinical Trial Site
Fuchu, Japan, 183-0042
Status
N/A
Location
Clinical Trial Site
Fukuoka, Japan, 814-0180
Status
N/A
Location
Clinical Trial Site
Gifu, Japan, 501-1194
Status
N/A
Location
Clinical Trial Site
Hiroshima, Japan, 730-8518
Status
N/A