Study Purpose:
The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis , ALS
Study Type:
Interventional
Type of Intervention:
Drug, Biological
Intervention Name:
Placebo, Ravulizumab
Placebo:
Yes
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
United States
Study Sponsor:
Alexion
Estimated Enrollment:
382
Estimated Study Start Date:
03 / 30 / 2020
Estimated Study Completion Date:
10 / 17 / 2021
Posting Last Modified Date:
01 / 10 / 2023
Date Study Added to neals.org:
01 / 30 / 2020
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
Key Inclusion Criteria:1. A diagnosis of sporadic or familial ALS, defined by the El Escorial criteria (possible, laboratory-supported probable, probable, or definite ALS).
2. ALS onset ≤ 36 months from Screening.
3. Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
4. Upright slow vital capacity ≥ 65% predicted at Screening.
5. 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).
6. Body weight ≥ 40 kilograms at Screening.
7. 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:
1. History of Neisseria meningitidis infection.
2. Human immunodeficiency virus (HIV) infection (evidenced by HIV 1 or HIV 2 antibody titer).
3. Dependence on invasive or non-invasive mechanical ventilation.
4. Previously or currently treated with a complement inhibitor.
5. Exposure to an investigational drug or device within 30 days of Screening or 5 half lives of the study drug, whichever is greater.
Barrow Neurological Institute
Phoenix, Arizona
85013
United States
HonorHealth Research Institute
Scottsdale, Arizona
85251
United States
Neuromuscular Research Center and Clinic
Phoenix, Arizona
85028
United States
University of California San Diego Medical Center
San Diego, California
92093-0949
United States
University of California San Francisco Medical Center
San Francisco, California
94143
United States
Norris MDA/ALS Center
San Francisco, California
94115
United States
Stanford University Medical Center
Palo Alto, California
94304
United States
University of California-Irvine
Orange, California
92868
United States
University of Southern California
Los Angeles, California
90033
United States
Loma Linda University Medical Center
Loma Linda, California
92354
United States
University of Colorado Anschutz Medical Campus School of Medicine
Aurora, Colorado
80045
United States
University of Florida at Shands Jacksonville
Jacksonville, Florida
32209
United States
University of South Florida
Tampa, Florida
33612
United States
University of Chicago Medical Center
Chicago, Illinois
60637
United States
Indiana University Medical Center
Indianapolis, Indiana
46202
United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas
66160
United States
University of Kentucky
Lexington, Kentucky
40536
United States
Johns Hopkins University School Of Medicine
Baltimore, Maryland
21205
United States
Massachusetts General Hospital
Boston, Massachusetts
02114
United States
Las Vegas Clinic
Las Vegas, Nevada
89145
United States
Beth Israel Medical Center - PRIME
New York, New York
10003
United States
Hospital for Special Surgery
New York, New York
10021
United States
Atrium Health Neuroscience Institute
Charlotte, North Carolina
28207
United States
The Cleveland Clinic Foundation
Cleveland, Ohio
44195
United States
The Ohio State University
Columbus, Ohio
43221
United States
Allegheny Neurological Associates
Pittsburgh, Pennsylvania
15212
United States
Vanderbilt University Medical Center
Nashville, Tennessee
37232
United States
Austin Neuromuscular Center
Austin, Texas
78756
United States
Houston Methodist Neurological Institute-Movement Disorders Clinic
Houston, Texas
77030
United States
Nerve & Muscle Center of Texas
Houston, Texas
77030
United States
University of Vermont Medical Center
Burlington, Vermont
05401
United States
Virginia Commonwealth University, Neurology Clinical and Translational Research Office
Richmond, Virginia
23298
United States
Sentara Neurology Specialists
Virginia Beach, Virginia
23456
United States
Swedish Neuroscience Institute
Seattle, Washington
98122-4470
United States
Brain and Mind Centre
Camperdown, New South Wales
2050
Australia
Royal Brisbane and Women's Hospital
Herston, Queensland
4029
Australia
Perron Institute for Neurological and Translational Science
Nedlands, Western Australia
6009
Australia
Westmead Hospital
Westmead, New South Wales
2145
Australia
UZ Leuven
Leuven 3000
Belgium
University Hospital of Quebec-Universite Laval
Québec, Quebec
G1J 1Z4
Canada
Royal University Hospital
Saskatoon, Saskatchewan
S7K 0M7
Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec
H3A 2B4
Canada
Toronto Sunnybrook Hospital
Toronto, Ontario
M4N 3M5
Canada
LHSC - University Hospital
London, Ontario
N6A 5A5
Canada
Stan Cassidy Center for Rehabilitation
Fredericton, New Brunswick
E3B 0C7
Canada
Heritage Medical Research Centre (HMRC)
Edmonton, Alberta
T6G2S2
Canada
Ålborg Universitets Hospital
Aalborg 9100
Denmark
Aarhus University Hospital Department of Neurology
Aarhus 8200
Denmark
Bispebjerg Hospital
Copenhagen 2400
Denmark
Hopital Roger Salengro - CHU Lille
Lille 59037
France
Groupe Hospitalier Pitie-Salpetriere
Paris cedex 13 75651
France
Hôpital de la Timone
Marseille 13385
France
CHU de Nice Hôpital Pasteur 2
Nice Cedex 1, Alpes Maritimes
06001
France
Hopital Neurologique Pierre Wertheimer
Bron cedex, Rhone
69677
France
CHU Tours - Hôpital Bretonneau
Tours Cedex 9, Indre Et Loire
37044
France
Hopital Gui de Chauliac
Montpellier, Herault
34295
France
CHU de Limoges - Hôpital Dupuytren
Limoges cedex, Haute Vienne
87042
France
Universitaetsklinikum Ulm
Ulm, Baden Wuerttemberg
89081
Germany
Klinikum rechts der Isar der TU Muenchen
Muenchen, Bayern
81675
Germany
Universitaetsmedizin Goettingen
Goettigen, Niedersachsen
37099
Germany
Medizinische Hochschule Hannover
Hannover, Niedersachsen
30625
Germany
Universitaetsklinikum Jena
Jena, Thueringen
07749
Germany
Beaumont Hospital
Dublin DUBLIN 9
Ireland
Tel Aviv Sourasky Medical Center
Tel Aviv 6423906
Israel
Hadassah University Hospital - Ein Kerem
Jerusalem 91120
Israel
Rambam Health Care Center
Haifa 91096
Israel
ICS Maugeri IRCCS
Milano 20138
Italy
Istituto Auxologico Italiano
Milano 20149
Italy
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Modena 1355 - 41126
Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo 90127
Italy
Azienda Ospedaliero Universitaria Pisana
Pisa 56126
Italy
University of Turin
Torino 10126
Italy
Ospedale San Raffaele
Milano 20132
Italy
Shiga University of Medical Science Hospital
Ōtsu, Shiga-Ken
520-2192
Japan
Keio University Hospital
Shinjuku-Ku, Tokyo-To
160-8582
Japan
Toho University Omori Medical Center
Ota-ku, Tokyo-To
143-8541
Japan
Tokushima University Hospital
Tokushima-shi, Tokushima-Ken
770-8503
Japan
Medical Hospital, Tokyo Medical and Dental University
Bunkyo-ku, Tokyo-To
113-8519
Japan
Niigata University Medical & Dental Hospital
Niigata-shi, Niigata-Ken
951-8520
Japan
Yoshino Neurology Clinic
Ichikawa-shi, Chiba-Ken
272-0827
Japan
Chiba University Hospital
Chiba-shi, Chiba-Ken
260-8677
Japan
Nagoya University Hospital
Nagoya-shi, Aichi-Ken
466-8560
Japan
Tohoku University Hospital
Sendai-shi, Miyagi-Ken
980-8574
Japan
University Medical Centre Utrecht
Utrecht 3508 GA
Netherlands
CityClinic
Warszawa 02-473
Poland
Hospital San Rafael
Madrid 28016
Spain
Hospital Universitari i Politecnic La Fe
Valencia 46026
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona 08025
Spain
Hospital Universitari Vall d'Hebron
Barcelona 08035
Spain
Hospital Universitari de Bellvitge
L'Hospitalet De Llobregat, Barcelona
08907
Spain
Karolinska Trial Alliance (KTA)
Huddinge 141 86
Sweden
Norrlands universitetssjukhus
Umeå 90185
Sweden
Kantonsspital St. Gallen
Saint Gallen 9007
Switzerland
The National Hospital for Neurology & Neurosurgery
London, Greater London
WC1N 3BG
United Kingdom
Royal Hallamshire Hospital
Sheffield, West Midlands
S10 2JF
United Kingdom