URGENT: The COVID-19 epidemic is severely impacting the progress of ALS research at the ALS Therapy Development Institute. If you are able to give, will you please provide an immediate gift to fund our lab?
Quick Info
Status
Currently Recruiting
Estimated Enrollment
354
Phase
3
Treatment Type
Intravenous Infusion
Trial Type
Primary Investigator
Primary investigator not known.
Contact Information
Locations
Canada, New Brunswick
Stan Cassidy Center for Rehabilitation, Fredericton, NB, E3B 0C7, Canada
Canada, Quebec
Montreal Neurological Institute and Hospital, Montreal, QC, H3A 2B4, Canada
Montreal Neurological Institute & Hospital, Montreal, QC, H3A24B, Canada
France, Other
Hopital Gui de Chauliac, Herault, 34295, France
CHU de Limoges - Hôpital Dupuytren, Limoges cedex, 87042, France
Hopital Gui de Chauliac, Montpellier, 34295, France
CHU de Nice Hôpital Pasteur 2, Nice Cedex 1, 06001, France
CHU de Nice Hôpital Pasteur 2, Nice Cedex 1, Alpes Maritimes, 06001, France
CHU Tours - Hôpital Bretonneau, Tours Cedex 9, 37044, France
Italy, Other
ICS Maugeri IRCCS, Milano, 20138, Italy
ICS Maugeri IRCCS, Milano, 20138, Italy
Japan, Other
Yoshino Neurology Clinic, Chiba-Ken, 272-0827, Japan
Yoshino Neurology Clinic, Ichikawa-shi, 272-0827, Japan
Niigata University Medical & Dental Hospital, Niigata-Ken, 951-8520, Japan
Niigata University Medical & Dental Hospital, Niigata-shi, 951-8520, Japan
Shiga University of Medical Science Hospital, Ōtsu, 520-2192, Japan
Tokushima University Hospital, Tokushima-Ken, 770-8503, Japan
Tokushima University Hospital, Tokushima-shi, 770-8503, Japan
Netherlands, Other
University Medical Centre Utrecht, Utrecht, 3508 GA, Netherlands
Spain, Other
Hospital Universitari de Bellvitge, Barcelona, 08907, Spain
Hospital Universitari de Bellvitge, L'Hospitalet De Llobregat, 08907, Spain
Hospital San Rafael, Madrid, 28016, Spain
Hospital San Rafael, Madrid, 28016, Spain
Sweden, Other
Norrlands universitetssjukhus, Umeå, 90185, Sweden
Norrlands universitetssjukhus, Umeå, 90185, Sweden
Switzerland, Other
Kantonsspital St. Gallen, Saint Gallen, 9007, Switzerland
United States, Arizona
Barrow Neurological Institute, Phoenix, AZ, 85013, United States
Barrow Neurological Institute, Phoenix, AZ, 85013, United States
Neuromuscular Research Center and Clinic, Phoenix, AZ, 85028, United States
Neuromuscular Research Center and Clinic, Phoenix, AZ, 85028, United States
United States, California
Loma Linda University Medical Center, Loma Linda, CA, 92354, United States
Loma Linda University Medical Center, Loma Linda, CA, 92354, United States
University of California-Irvine, Orange, CA, 92868, United States
University of California-Irvine, Orange, CA, 92868, United States
United States, Colorado
University of Colorado Anschutz Medical Campus School of Medicine, Aurora, CO, 80045, United States
University of Colorado Anschutz Medical Campus School of Medicine, Aurora, CO, 80045, United States
United States, Florida
University of Soth Florida, Tampa, FL, 33612, United States
University of South Florida, Tampa, FL, 33612, United States
United States, Indiana
Indiana University Medical Center, Indianapolis, IN, 46202, United States
United States, Massachusetts
Massachusetts General Hospital, Boston, MA, 02114, United States
Massachusetts General Hospital, Boston, MA, 02114, United States
United States, Nevada
Las Vegas Clinic , Las Vegas, NV, 89145, United States
Las Vegas Clinic, Las Vegas, NV, 89145, United States
United States, New York
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
The Ohio State University, Columbus, OH, 43221, United States
The Ohio State University, Columbus, OH, 43221, United States
United States, Texas
Austin Neuromuscular Center, Austin, TX, 78756, United States
Austin Neuromuscular Center, Austin, TX, 78756, United States
Houston Methodist Neurological Institute-Movement Disorders Clinic, Houston, 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
Nerve & Muscle Center of Texas, Houston, TX, 77030, United States
United States, Virginia
Sentara Neurology Specialists, Virginia Beach, VA, 23456, United States
Sentara Neurology Specialists, Virginia Beach, VA, 23456, United States
United States, Washington
Swedish Neuroscience Institute, Seattle, WA, 98122, 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.
N/A
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
Update Notes
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
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. 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)