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Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment — Phoenix  

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial Summary

The Phoenix Trial is a randomized double blind placebo controlled Phase III trial to evaluate the safety and efficacy of AMX0035 for 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 and survival over 48 week. The trial will also assess the effects of AMX0035 on slow vital capacity, quality of life and plasma biomarkers of ALS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05021536
Study type Interventional
Source Amylyx Pharmaceuticals Inc.
Contact
Status Active, not recruiting
Phase Phase 3
Start date October 28, 2021
Completion date March 1, 2024
View Details
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