Back to resultsAn Efficacy and Safety Study of Ravulizumab in ALS Participants
Primary Purpose
Amyotrophic Lateral Sclerosis, ALS
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Ravulizumab
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Ravulizumab, ALXN1210, Ultomiris, Motor Neuron Disease, Amyotrophic Lateral Sclerosis, ALS
Eligibility Criteria
Key Inclusion Criteria:
- A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria (possible, laboratory-supported probable, probable, or definite ALS).
- ALS onset ≤ 36 months from Screening.
- Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
- Upright slow vital capacity ≥ 65% predicted at Screening.
- If on riluzole, participant must be on a stable dose for 30 days; if on edaravone, participant must be on a stable dose for 60 days (2 cycles).
- Body weight ≥ 40 kilograms at Screening.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Key Exclusion Criteria:
- History of Neisseria meningitidis infection.
- Human immunodeficiency virus (HIV) infection (evidenced by HIV 1 or HIV 2 antibody titer).
- Dependence on invasive or non-invasive mechanical ventilation.
- Previously or currently treated with a complement inhibitor.
- Exposure to an investigational drug or device within 30 days of Screening or 5 half lives of the study drug, whichever is greater.
Sites / Locations
- Barrow Neurological Institute
- Neuromuscular Research Center and Clinic
- HonorHealth Research Institute
- Loma Linda University Medical Center
- University of Southern California
- University of California-Irvine
- Stanford University Medical Center
- University of California San Diego Medical Center
- Norris MDA/ALS Center
- University of California San Francisco Medical Center
- University of Colorado Anschutz Medical Campus School of Medicine
- University of Florida at Shands Jacksonville
- University of South Florida
- University of Chicago Medical Center
- Indiana University Medical Center
- University of Kansas Medical Center Research Institute, Inc.
- University of Kentucky
- Johns Hopkins University School Of Medicine
- Massachusetts General Hospital
- Las Vegas Clinic
- Beth Israel Medical Center - PRIME
- Hospital for Special Surgery
- Atrium Health Neuroscience Institute
- The Cleveland Clinic Foundation
- The Ohio State University
- Allegheny Neurological Associates
- Vanderbilt University Medical Center
- Austin Neuromuscular Center
- Houston Methodist Neurological Institute-Movement Disorders Clinic
- Nerve & Muscle Center of Texas
- University of Vermont Medical Center
- Virginia Commonwealth University, Neurology Clinical and Translational Research Office
- Sentara Neurology Specialists
- Swedish Neuroscience Institute
- Brain and Mind Centre
- Westmead Hospital
- Royal Brisbane and Women's Hospital
- Perron Institute for Neurological and Translational Science
- UZ Leuven
- Heritage Medical Research Centre (HMRC)
- Stan Cassidy Center for Rehabilitation
- LHSC - University Hospital
- Toronto Sunnybrook Hospital
- Montreal Neurological Institute and Hospital
- University Hospital of Quebec-Universite Laval
- Royal University Hospital
- Ålborg Universitets Hospital
- Aarhus University Hospital Department of Neurology
- Bispebjerg Hospital
- CHU de Nice Hôpital Pasteur 2
- CHU de Limoges - Hôpital Dupuytren
- Hopital Gui de Chauliac
- CHU Tours - Hôpital Bretonneau
- Hopital Neurologique Pierre Wertheimer
- Hopital Roger Salengro - CHU Lille
- Hôpital de la Timone
- Groupe Hospitalier Pitie-Salpetriere
- Universitaetsklinikum Ulm
- Klinikum rechts der Isar der TU Muenchen
- Universitaetsmedizin Goettingen
- Medizinische Hochschule Hannover
- Universitaetsklinikum Jena
- Beaumont Hospital
- Rambam Health Care Center
- Hadassah University Hospital - Ein Kerem
- Tel Aviv Sourasky Medical Center
- Ospedale San Raffaele
- ICS Maugeri IRCCS
- Istituto Auxologico Italiano
- Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
- Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
- Azienda Ospedaliero Universitaria Pisana
- University of Turin
- Nagoya University Hospital
- Chiba University Hospital
- Yoshino Neurology Clinic
- Tohoku University Hospital
- Niigata University Medical & Dental Hospital
- Shiga University of Medical Science Hospital
- Tokushima University Hospital
- Medical Hospital, Tokyo Medical and Dental University
- Toho University Omori Medical Center
- Keio University Hospital
- University Medical Centre Utrecht
- CityClinic
- Hospital Universitari de Bellvitge
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitari Vall d'Hebron
- Hospital San Rafael
- Hospital Universitari i Politecnic La Fe
- Karolinska Trial Alliance (KTA)
- Norrlands universitetssjukhus
- Kantonsspital St. Gallen
- The National Hospital for Neurology & Neurosurgery
- Royal Hallamshire Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ravulizumab
Placebo
Arm Description
Participants will receive ravulizumab for the duration of the study.
Participants will receive placebo during the 50-week Randomized Controlled Period of the study, after which they will enter the Open-label Extension Period of the study and switch to receive ravulizumab.
Outcomes
Primary Outcome Measures
Change From Baseline In Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Total Score
The ALSFRS-Revised is a validated instrument for evaluating the levels of the functional status of participants with amyotrophic lateral sclerosis (ALS) in 4 areas, including bulbar, gross motor activity, fine motor activity, and respiratory functions. The scale included 12 functional items and each item is rated on a 0 to 4 scale, with a maximum total score of 48. A higher score indicated greater retention of function. Baseline was defined as last non-missing value on or before first study drug administration.
Secondary Outcome Measures
Time To Ventilator Assistance-free Survival
Ventilation Assistance-Free Survival (VAFS) is a composite endpoint of survival and severe and irreversible respiratory decline. The use of VAFS allowed for the collection of survival data that was not impacted by survival prolongation from noninvasive or permanent ventilatory interventions which could prolong life without impacting underlying disease progression.
Change From Baseline In Percent Predicted Slow Vital Capacity
Slow vital capacity measures slow and gradual expulsion of air from the lungs using a spirometer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events, and TEAEs Leading To Study Drug Discontinuation
An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Change From Baseline In Muscle Strength As Assessed By Handheld Dynamometry
Handheld dynamometry (HHD) is a procedure for quantitative strength testing. Muscle strength testing was performed on prespecified muscles in the upper and lower extremities bilaterally and the force measurements were recorded. Force of measurement is reported in megascores (lower, upper, total). The total megascore is defined as the average of the non-missing ratios over baseline for all the muscles involved. The megascore at baseline is always 100. The range of a potential megascore can not be determined in advance. A megascore >100 indicates more strength compared to baseline.
Change From Baseline In Serum Neurofilament Light Chain
Change From Baseline in Serum Ravulizumab Concentration Over the Study Duration
Change From Baseline in Serum Free Complement Component 5 (C5) Concentration Over the Study Duration
Number of Participants With Positive Antidrug Antibodies (ADAs) to ALXN1210
Blood samples were collected to evaluate antibody response through development of ADAs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04248465
Brief Title
An Efficacy and Safety Study of Ravulizumab in ALS Participants
Official Title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
The IDMC recommended the study be discontinued due to lack of efficacy with ravulizumab.
Study Start Date
March 30, 2020 (Actual)
Primary Completion Date
October 17, 2021 (Actual)
Study Completion Date
October 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis, ALS
Keywords
Ravulizumab, ALXN1210, Ultomiris, Motor Neuron Disease, Amyotrophic Lateral Sclerosis, ALS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
382 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ravulizumab
Arm Type
Experimental
Arm Description
Participants will receive ravulizumab for the duration of the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo during the 50-week Randomized Controlled Period of the study, after which they will enter the Open-label Extension Period of the study and switch to receive ravulizumab.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight.
Intervention Type
Biological
Intervention Name(s)
Ravulizumab
Other Intervention Name(s)
ALXN1210, Ultomiris
Intervention Description
Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight.
Primary Outcome Measure Information:
Title
Change From Baseline In Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Total Score
Description
The ALSFRS-Revised is a validated instrument for evaluating the levels of the functional status of participants with amyotrophic lateral sclerosis (ALS) in 4 areas, including bulbar, gross motor activity, fine motor activity, and respiratory functions. The scale included 12 functional items and each item is rated on a 0 to 4 scale, with a maximum total score of 48. A higher score indicated greater retention of function. Baseline was defined as last non-missing value on or before first study drug administration.
Time Frame
Baseline, Week 50
Secondary Outcome Measure Information:
Title
Time To Ventilator Assistance-free Survival
Description
Ventilation Assistance-Free Survival (VAFS) is a composite endpoint of survival and severe and irreversible respiratory decline. The use of VAFS allowed for the collection of survival data that was not impacted by survival prolongation from noninvasive or permanent ventilatory interventions which could prolong life without impacting underlying disease progression.
Time Frame
Up to Week 50
Title
Change From Baseline In Percent Predicted Slow Vital Capacity
Description
Slow vital capacity measures slow and gradual expulsion of air from the lungs using a spirometer.
Time Frame
Baseline, Week 50
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events, and TEAEs Leading To Study Drug Discontinuation
Description
An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time Frame
Baseline up to Week 156
Title
Change From Baseline In Muscle Strength As Assessed By Handheld Dynamometry
Description
Handheld dynamometry (HHD) is a procedure for quantitative strength testing. Muscle strength testing was performed on prespecified muscles in the upper and lower extremities bilaterally and the force measurements were recorded. Force of measurement is reported in megascores (lower, upper, total). The total megascore is defined as the average of the non-missing ratios over baseline for all the muscles involved. The megascore at baseline is always 100. The range of a potential megascore can not be determined in advance. A megascore >100 indicates more strength compared to baseline.
Time Frame
Baseline, Week 50
Title
Change From Baseline In Serum Neurofilament Light Chain
Time Frame
Baseline, Week 50
Title
Change From Baseline in Serum Ravulizumab Concentration Over the Study Duration
Time Frame
Baseline, Predose at Week 50
Title
Change From Baseline in Serum Free Complement Component 5 (C5) Concentration Over the Study Duration
Time Frame
Baseline, Predose at Week 50
Title
Number of Participants With Positive Antidrug Antibodies (ADAs) to ALXN1210
Description
Blood samples were collected to evaluate antibody response through development of ADAs.
Time Frame
Week 50
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria (possible, laboratory-supported probable, probable, or definite ALS).
ALS onset ≤ 36 months from Screening.
Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
Upright slow vital capacity ≥ 65% predicted at Screening.
If on riluzole, participant must be on a stable dose for 30 days; if on edaravone, participant must be on a stable dose for 60 days (2 cycles).
Body weight ≥ 40 kilograms at Screening.
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Key Exclusion Criteria:
History of Neisseria meningitidis infection.
Human immunodeficiency virus (HIV) infection (evidenced by HIV 1 or HIV 2 antibody titer).
Dependence on invasive or non-invasive mechanical ventilation.
Previously or currently treated with a complement inhibitor.
Exposure to an investigational drug or device within 30 days of Screening or 5 half lives of the study drug, whichever is greater.
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Neuromuscular Research Center and Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
HonorHealth Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California-Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92093-0949
Country
United States
Facility Name
Norris MDA/ALS Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of California San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida at Shands Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center Research Institute, Inc.
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Johns Hopkins University School Of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Las Vegas Clinic
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Facility Name
Beth Israel Medical Center - PRIME
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Atrium Health Neuroscience Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Allegheny Neurological Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Austin Neuromuscular Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Houston Methodist Neurological Institute-Movement Disorders Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Nerve & Muscle Center of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Virginia Commonwealth University, Neurology Clinical and Translational Research Office
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Sentara Neurology Specialists
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4470
Country
United States
Facility Name
Brain and Mind Centre
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Perron Institute for Neurological and Translational Science
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Heritage Medical Research Centre (HMRC)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2S2
Country
Canada
Facility Name
Stan Cassidy Center for Rehabilitation
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 0C7
Country
Canada
Facility Name
LHSC - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Toronto Sunnybrook Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
University Hospital of Quebec-Universite Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0M7
Country
Canada
Facility Name
Ålborg Universitets Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Aarhus University Hospital Department of Neurology
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
CHU de Nice Hôpital Pasteur 2
City
Nice Cedex 1
State/Province
Alpes Maritimes
ZIP/Postal Code
06001
Country
France
Facility Name
CHU de Limoges - Hôpital Dupuytren
City
Limoges cedex
State/Province
Haute Vienne
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Gui de Chauliac
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Tours - Hôpital Bretonneau
City
Tours Cedex 9
State/Province
Indre Et Loire
ZIP/Postal Code
37044
Country
France
Facility Name
Hopital Neurologique Pierre Wertheimer
City
Bron cedex
State/Province
Rhone
ZIP/Postal Code
69677
Country
France
Facility Name
Hopital Roger Salengro - CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Groupe Hospitalier Pitie-Salpetriere
City
Paris cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Universitaetsklinikum Ulm
City
Ulm
State/Province
Baden Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Klinikum rechts der Isar der TU Muenchen
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsmedizin Goettingen
City
Goettigen
State/Province
Niedersachsen
ZIP/Postal Code
37099
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Jena
City
Jena
State/Province
Thueringen
ZIP/Postal Code
07749
Country
Germany
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
DUBLIN 9
Country
Ireland
Facility Name
Rambam Health Care Center
City
Haifa
ZIP/Postal Code
91096
Country
Israel
Facility Name
Hadassah University Hospital - Ein Kerem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
ICS Maugeri IRCCS
City
Milano
ZIP/Postal Code
20138
Country
Italy
Facility Name
Istituto Auxologico Italiano
City
Milano
ZIP/Postal Code
20149
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
City
Modena
ZIP/Postal Code
1355 - 41126
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
University of Turin
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Nagoya University Hospital
City
Nagoya-shi
State/Province
Aichi-Ken
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba-shi
State/Province
Chiba-Ken
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Yoshino Neurology Clinic
City
Ichikawa-shi
State/Province
Chiba-Ken
ZIP/Postal Code
272-0827
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi-Ken
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata-shi
State/Province
Niigata-Ken
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Ōtsu
State/Province
Shiga-Ken
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima-shi
State/Province
Tokushima-Ken
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Medical Hospital, Tokyo Medical and Dental University
City
Bunkyo-ku
State/Province
Tokyo-To
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Toho University Omori Medical Center
City
Ota-ku
State/Province
Tokyo-To
ZIP/Postal Code
143-8541
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-Ku
State/Province
Tokyo-To
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
University Medical Centre Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Facility Name
CityClinic
City
Warszawa
ZIP/Postal Code
02-473
Country
Poland
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital San Rafael
City
Madrid
ZIP/Postal Code
28016
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Karolinska Trial Alliance (KTA)
City
Huddinge
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Norrlands universitetssjukhus
City
Umeå
ZIP/Postal Code
90185
Country
Sweden
Facility Name
Kantonsspital St. Gallen
City
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
The National Hospital for Neurology & Neurosurgery
City
London
State/Province
Greater London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
West Midlands
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
An Efficacy and Safety Study of Ravulizumab in ALS Participants
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