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Quick Info
Status
This study has been completed
Estimated Enrollment
132
Phase
2
Treatment Type
Drug: AMX0035
Trial Type
Randomized, Parallel Assignment
Sponsor
Amylyx Pharmaceuticals Inc.
Primary Investigator
Sabrina Paganoni, MD
Contact Information
Locations
Barrow Neurological Institute, Phoenix, 85013
Forbes Norris MDA/ALS Research Center , San Francisco, 94114
UC Irvine Medical Center, Orange, 92868
Carol & Frank Morsini Center for Advanced HealthCa, Tampa, 33612
University of Florida Medical Center, Gainesville, 32610
Emory University Hospital, Atlanta, 30322
University of Iowa Hospitals and Clinics, Iowa City, 52242
University of Kentucky Medical Center , Lexington, 40536
Ochsner Neuroscience Institute, New Orleans, 70121
Massachusetts General Hospital, Boston, 02114
University of Massachusetts Memorial Medical Cente, Worcester, 01655
Johns Hopkins Hospital, Baltimore, 21287
University of Michigan Medical Center, Ann Arbor, 48109
Hennepin County Medical Center, Minneapolis, 55415
Washington University Medical Center, Saint Louis, 63110
Wake Forest Baptist Medical Center, Winston-Salem, 27157
Neurology Associates P.C., Lincoln, 68506
Mount Sinai Beth Israel, New York, 10003
The Ohio State University Wexner Medical Center , Columbus, 43221
Oregon Health & Science University , Portland, 97239
The Penn Comprehensive ALS Center, Philadelphia, 19107
Temple University Hospital, Philadelphia, 19140
Texas Neurology, P.A., Dallas, 75214
University of Texas Health Science Center at San A, San Antonio, 78229
ALS Center at the Swedish Neuroscience Institute, Seattle, 98122
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
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)
News Articles and Summaries
ALS Forum
View Forum Link
Trial Protocol as Published on Clinicaltrials.gov
NCT03127514 (First Published: 4/12/2017)
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