Your support fuels our research to #EndALS!
Quick Info
Status
Currently Recruiting
Phase
3
Trial Type
Interventional
Treatment Type
Intravenous Infusion
Randomization
2:1
Enrollment
354
Start Date
3/30/2020
Contact Information
Locations
Australia, Other
Royal Brisbane and Women's Hospital, Herston, 4029, Australia
Perron Institute for Neurological and Translational Science, Nedlands, 6009, Australia
Westmead Hospital, Westmead, 2145, Australia
Canada, Alberta
Heritage Medical Research Centre (HMRC), Edmonton, AB, T6G2S2, Canada
Canada, New Brunswick
Stan Cassidy Center for Rehabilitation, Fredericton, NB, E3B 0C7, Canada
Canada, Ontario
LHSC - University Hospital, London, ON, N6A 5A5, Canada
Canada, Quebec
Montreal Neurological Institute and Hospital, Montreal, QC, H3A 2B4, Canada
University Hospital of Quebec-Universite Laval, Québec, QC, G1J 1Z4, Canada
Canada, Saskatchewan
Royal University Hospital, Saskatoon, SK, S7K 0M7, Canada
Denmark, Other
Ålborg Universitets Hospital, Aalborg, 9100, Denmark
Aarhus University Hospital Department of Neurology, Aarhus, 8200, Denmark
Bispebjerg Hospital, Copenhagen, 2400, Denmark
France, Other
Hopital Neurologique Pierre Wertheimer, Bron cedex, 69677, France
Hopital Roger Salengro - CHU Lille, Lille, 59037, France
CHU de Limoges - Hôpital Dupuytren, Limoges cedex, 87042, France
Hôpital de la Timone, Marseille, 13385, France
Hopital Gui de Chauliac, Montpellier, 34295, France
CHU de Nice Hôpital Pasteur 2, Nice Cedex 1, 06001, France
Groupe Hospitalier Pitie-Salpetriere, Paris cedex 13, 75651, France
CHU Tours - Hôpital Bretonneau, Tours Cedex 9, 37044, France
Germany, Other
Universitaetsmedizin Goettingen, Goettigen, 37099, Germany
Italy, Other
Ospedale San Raffaele, Milano, 20132, Italy
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
Japan, Other
Medical Hospital, Tokyo Medical and Dental University, Bunkyo-ku, 113-8519, Japan
Chiba University Hospital, Chiba-shi, 260-8677, Japan
Yoshino Neurology Clinic, Ichikawa-shi, 272-0827, Japan
Nagoya University Hospital, Nagoya-shi, 466-8560, Japan
Niigata University Medical & Dental Hospital, Niigata-shi, 951-8520, Japan
Shiga University of Medical Science Hospital, Ōtsu, 520-2192, Japan
Tohoku University Hospital, Sendai, 980-8574, Japan
Tohoku University Hospital, Sendai-shi, 980-8574, Japan
Keio University Hospital, Shinjuku-Ku, 160-8582, Japan
Tokushima University Hospital, Tokushima-shi, 770-8503, Japan
Netherlands, Other
University Medical Centre Utrecht, Utrecht, 3508 GA, Netherlands
Poland, Other
CityClinic, Warszawa, 02-473, Poland
Spain, Other
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, 08907, Spain
Hospital San Rafael, Madrid, 28016, Spain
Hospital Universitari i Politecnic La Fe, Valencia, 46026, Spain
Sweden, Other
Karolinska Trial Alliance (KTA), Huddinge, 141 86, Sweden
Norrlands universitetssjukhus, Umeå, 90185, Sweden
Switzerland, Other
Kantonsspital St. Gallen, Saint Gallen, 9007, Switzerland
United Kingdom, Other
The National Hospital for Neurology & Neurosurgery, London, WC1N 3BG, United Kingdom
United States, Arizona
Barrow Neurological Institute, Phoenix, AZ, 85013, United States
Neuromuscular Research Center and Clinic, Phoenix, AZ, 85028, United States
HonorHealth Research Institute, Scottsdale, AZ, 85251, United States
United States, California
Loma Linda University Medical Center, Loma Linda, CA, 92354, United States
University of Southern California, Los Angeles, CA, 90033, United States
University of California-Irvine, Orange, CA, 92868, United States
Stanford University Medical Center, Palo Alto, CA, 94304, United States
University of California San Diego Medical Center, San Diego, CA, 92093-0949, United States
Norris MDA/ALS Center, San Francisco, CA, 94115, United States
University of California San Francisco Medical Center, San Francisco, CA, 94143, United States
United States, Colorado
University of Colorado Anschutz Medical Campus School of Medicine, Aurora, CO, 80045, United States
United States, Florida
University of Florida at Shands Jacksonville, Jacksonville, FL, 32209, United States
University of South Florida, Tampa, FL, 33612, United States
United States, Illinois
University of Chicago Medical Center, Chicago, IL, 60637, United States
United States, Indiana
Indiana University Medical Center, Indianapolis, IN, 46202, United States
United States, Kansas
University of Kansas Medical Center Research Institute, Inc., Kansas City, KS, 66160, United States
United States, Kentucky
University of Kentucky, Lexington, KY, 40536, United States
United States, Maryland
Johns Hopkins University School Of Medicine, Baltimore, MD, 21205, United States
United States, Massachusetts
Massachusetts General Hospital, Boston, MA, 02114, United States
United States, Nevada
Las Vegas Clinic, Las Vegas, NV, 89145, United States
United States, New York
Beth Israel Medical Center - PRIME, New York, NY, 10003, United States
Hospital for Special Surgery, New York, NY, 10021, United States
United States, North Carolina
Atrium Health Neuroscience Institute, Charlotte, NC, 28207, United States
United States, Ohio
The Cleveland Clinic Foundation, Cleveland, OH, 44195, United States
The Ohio State University, Columbus, OH, 43221, United States
United States, Pennsylvania
Allegheny Neurological Associates, Pittsburgh, PA, 15212, United States
United States, Tennessee
Vanderbilt University Medical Center, Nashville, TN, 37232, United States
United States, Texas
Austin Neuromuscular Center, Austin, TX, 78756, United States
Houston Methodist Neurological Institute-Movement Disorders Clinic, Houston, TX, 77030, United States
Nerve & Muscle Center of Texas, Houston, TX, 77030, United States
United States, Vermont
University of Vermont Medical Center, Burlington, VT, 05401, United States
United States, Virginia
Sentara Neurology Specialists, Virginia Beach, VA, 23456, United States
United States, Washington
Swedish Neuroscience Institute, Seattle, WA, 98122-4470, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
N/A
Months Since Onset
Number of months since first symptoms of ALS.
<36 months
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
N/A
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
N/A
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Open Label
Yes
Update Notes
New sites added
1/11/2021
New sites, start date updated
12/8/2020
New sites added
11/9/2020
New US locations added.
10/13/2020
New locations added
9/9/2020
New locations added
8/19/2020
Locations added in Arizona and Texas
7/22/2020
Added new recruitment locations.
6/15/2020
No Significant Updates
4/29/2020
Updated recruitment status: Now Open
3/11/2020
New trial added
1/30/2020

Other Information

Purpose
The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.
Eligibility
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.
Details
Collaborator(s)
  • Alexion Pharmaceuticals
Trial Protocol as Published on Clinicaltrials.gov
NCT04248465 (First Published: 1/27/2020)