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AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS) — CENTAUR  

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
Evaluation of the Safety, Tolerability, Efficacy and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for the Treatment of ALS

Clinical Trial Summary

The CENTAUR trial was 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03127514
Study type Interventional
Source Amylyx Pharmaceuticals Inc.
Contact
Status Completed
Phase Phase 2
Start date June 22, 2017
Completion date November 24, 2019
View Details
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