Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment
NCT05021536 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- OTHER Placebo
- DRUG AMX0035
Study Locations (20)
California
- University of Southern California — Los Angeles
- University of California Irvine — Orange
- California Pacific Medical Center Research Institute — San Francisco
Florida
- University of Florida — Gainesville
- University of South Florida — Tampa
Georgia
- Emory University — Atlanta
- Augusta University Neuroscience Center — Augusta
Massachusetts
- Healey & AMG Center for ALS Research at Massachusetts General Hospital — Boston
- University of Massachusetts — Worcester
North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill
- Wake Forest University Health Sciences — Winston-Salem
Arizona
- Barrow Neurological Institute — Phoenix
Colorado
- University of Colorado — Aurora
Illinois
- Northwestern University — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 664 participants |
| Start Date | 2021-10-28 |
| Est. Completion | 2026-01-01 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05021536
The ClinicalTrials.gov registry entry for NCT05021536 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 664 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amylyx Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05021536 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05021536 about?
NCT05021536 is a clinical study titled "Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment". 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
What is the current status of trial NCT05021536?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 664 participants. The study started on 2021-10-28. Estimated completion is 2026-01-01.
What conditions does trial NCT05021536 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05021536?
The interventions under investigation include: Placebo (OTHER), AMX0035 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05021536?
This trial is sponsored by Amylyx Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05021536 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.