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Not listed Phase 3 Interventional

Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment

ClinicalTrials.gov ID: NCT05021536

Public ClinicalTrials.gov record NCT05021536. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT05021536
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Amylyx Pharmaceuticals Inc.
Industry
Enrollment
664 participants

Conditions and interventions

Interventions

Other · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 28, 2021 (Actual)
Primary completion
Jan 19, 2024 (Actual)
Completion
Jan 1, 2026 (Estimated)
Last update posted
Aug 14, 2024

2021 – 2026

United States locations

U.S. sites
28
U.S. states
19
U.S. cities
26
Facility City State ZIP Site status
Barrow Neurological Institute Phoenix Arizona 85013 —
University of Southern California Los Angeles California 90033 —
University of California Irvine Orange California 92868 —
California Pacific Medical Center Research Institute San Francisco California 94109 —
University of Colorado Aurora Colorado 80045 —
University of Florida Gainesville Florida 32068 —
University of South Florida Tampa Florida 33612 —
Emory University Atlanta Georgia 30322 —
Augusta University Neuroscience Center Augusta Georgia 30912 —
Northwestern University Chicago Illinois 60611 —
Johns Hopkins University School of Medicine Outpatient Center Baltimore Maryland 21287 —
Healey & AMG Center for ALS Research at Massachusetts General Hospital Boston Massachusetts 02114 —
University of Massachusetts Worcester Massachusetts 01655 —
Hennepin Healthcare Research Institute Minneapolis Minnesota 55415 —
Washington University School of Medicine St Louis Missouri 63110 —
Somnos Clinical Research Lincoln Nebraska 68510 —
Rutgers University New Brunswick New Jersey 08901 —
Columbia University New York New York 10032 —
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27514 —
Wake Forest University Health Sciences Winston-Salem North Carolina 27109 —
The Ohio State University Columbus Ohio 43210 —
University of Pennsylvania Philadelphia Pennsylvania 19107 —
Lewis Katz School of Medicine at Temple University Philadelphia Pennsylvania 19140 —
Austin Neuromuscular Center Austin Texas 78756 —
Texas Neurology Dallas Texas 72506 —
Virginia Commonwealth University Henrico Virginia 23233 —
Swedish Neuroscience Institute Seattle Washington 98122 —
University of Washington Seattle Washington 98195 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05021536, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 14, 2024 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05021536 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →