ALS Therapy Development Institute

AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)

AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)

Quick Info:

Status:
Currently Recruiting
Estimated Enrollment:
132
Phase:
2
Treatment Type:
Drug: AMX0035
Trial Type:
Randomized, Parallel Assignment
Sponsor:
Amylyx Pharmaceuticals Inc.
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
(SVC) >60%
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
less/equal to 18 months
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
not specified
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
No
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Yes

Update Notes:

11/10/2018No significant updates
9/25/2018No significant updates
6/5/2018Changed to Emily as Main Contact
3/23/2018Recruitment at location updated
1/31/2018Recruitment at locations updated
1/3/2018Recruitment status updated
12/20/2017
12/7/2017Recruitment status updated
11/30/2017Recruitment status updated
11/20/2017Recruitment status updated
11/9/2017Recruitment status updated
10/24/2017Recruitment status updated
10/11/2017Recruitment status updated
9/27/2017Recruitment status updated
9/8/2017Recruitment status updated
8/17/2017Recruitment status at location updated
8/7/2017Recruitment status at location updated
7/12/2017Recruitment status updated
6/19/2017No significant updates
6/13/2017Recruitment status updated
5/31/2017Contact info updated
4/26/2017Trial added

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

Other Information:

Purpose: 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.
Eligibility: 18-80 year, all genders, not accepting healthy volunteers
Details: 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
First Published on Clinicaltrials.gov: 4/12/2017
ClinicalTrials.gov ID: NCT03127514
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov