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Quick Info
Status
This study has been completed
Estimated Enrollment
137
Phase
2/3
Treatment Type
Drug: AMX0035
Trial Type
Randomized, Parallel Assignment
Sponsor
Amylyx Pharmaceuticals Inc.
Primary Investigator
Sabrina Paganoni, MD
Contact Information
Locations
United States, Arizona
Barrow Neurological Institute, Phoenix, AZ, 85013, United States
United States, California
UC Irvine Medical Center, Orange, CA, 92868, United States
Forbes Norris MDA/ALS Research Center , San Francisco, CA, 94114, United States
United States, Florida
University of Florida Medical Center, Gainesville, FL, 32610, United States
Carol & Frank Morsini Center for Advanced HealthCa, Tampa, FL, 33612, United States
United States, Georgia
Emory University Hospital, Atlanta, GA, 30322, United States
United States, Iowa
University of Iowa Hospitals and Clinics, Iowa City, IA, 52242, United States
United States, Kentucky
University of Kentucky Medical Center , Lexington, KY, 40536, United States
United States, Louisiana
Ochsner Neuroscience Institute, New Orleans, LA, 70121, United States
United States, Maryland
Johns Hopkins Hospital, Baltimore, MD, 21287, United States
United States, Massachusetts
Massachusetts General Hospital, Boston, MA, 02114, United States
University of Massachusetts Memorial Medical Cente, Worcester, MA, 01655, United States
United States, Michigan
University of Michigan Medical Center, Ann Arbor, MI, 48109, United States
United States, Minnesota
Hennepin County Medical Center, Minneapolis, MN, 55415, United States
United States, Missouri
Washington University Medical Center, Saint Louis, MO, 63110, United States
United States, Nebraska
Neurology Associates P.C., Lincoln, NE, 68506, United States
United States, New York
Mount Sinai Beth Israel, New York, NY, 10003, United States
United States, North Carolina
Wake Forest Baptist Medical Center, Winston-Salem, NC, 27157, United States
United States, Ohio
The Ohio State University Wexner Medical Center , Columbus, OH, 43221, United States
United States, Oregon
Oregon Health & Science University , Portland, OR, 97239, United States
United States, Pennsylvania
The Penn Comprehensive ALS Center, Philadelphia, PA, 19107, United States
Temple University Hospital, Philadelphia, PA, 19140, United States
United States, Texas
Texas Neurology, P.A., Dallas, TX, 75214, United States
University of Texas Health Science Center at San A, San Antonio, TX, 78229, United States
United States, Washington
ALS Center at the Swedish Neuroscience Institute, Seattle, WA, 98122, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
(SVC) >60%
Months Since Onset
Number of months since first symptoms of ALS.
less/equal to 18 months
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
not specified
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
No
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Update Notes
No significant updates.
5/29/2020
Trial has been completed
12/18/2019
No significant updates
10/10/2019
No significant updates
9/23/2019
Recruitment status updated
3/11/2019
Contact info updated
2/19/2019
No significant updates
11/10/2018
No significant updates
9/25/2018
Changed to Emily as Main Contact
6/5/2018
Recruitment at location updated
3/23/2018
Recruitment at locations updated
1/31/2018
Recruitment status updated
1/3/2018
12/20/2017
Recruitment status updated
12/7/2017
Recruitment status updated
11/30/2017
Recruitment status updated
11/20/2017
Recruitment status updated
11/9/2017
Recruitment status updated
10/24/2017
Recruitment status updated
10/11/2017
Recruitment status updated
9/27/2017
Recruitment status updated
9/8/2017
Recruitment status at location updated
8/17/2017
Recruitment status at location updated
8/7/2017
Recruitment status updated
7/12/2017
No significant updates
6/19/2017
Recruitment status updated
6/13/2017
Contact info updated
5/31/2017
Trial added
4/26/2017

Other Information

Purpose
Eligibility
18-80 year, all genders, not accepting healthy volunteers
Details
The CENTAUR trial will be a 2:1 (active:placebo) randomized, double-blind, placebo-controlled Phase II trial to evaluate the safety and efficacy of AMX0035 for the treatment of ALS. AMX0035 is a combination therapy designed to reduce neuronal death through blockade of key cellular death pathways originating in the mitochondria and endoplasmic reticulum (ER). This clinical trial is designed to demonstrate that treatment is safe, tolerable, and able to slow decline in function as measured by the ALSFRS-R. The trial will also assess the effects of AMX0035 on muscle strength, vital capacity, and biomarkers of ALS including markers of neuronal death and neuroinflammation.
Collaborator(s)
Trial Protocol as Published on Clinicaltrials.gov
NCT03127514 (First Published: 4/12/2017)
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