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NCT05021536 · ClinicalTrials.gov registry record · Phase 3
Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment
A Phase 3 study of Amyotrophic Lateral Sclerosis, sponsored by Amylyx Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 664
- Enrollment target
- 20
- Study locations
NCT05021536: Active Phase 3 study of Amyotrophic Lateral Sclerosis, sponsored by Amylyx Pharmaceuticals.
NCT05021536 is a Phase 3 study of Amyotrophic Lateral Sclerosis that is active but no longer recruiting, run by Amylyx Pharmaceuticals. The registered enrollment target is 664 participants, below the 891-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05021536, a Phase 3 study of Amyotrophic Lateral Sclerosis, is active but no longer recruiting, sponsored by Amylyx Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 664 participants
- Enrollment target
- 20
- Study locations
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 |
What the registry record for NCT05021536 still lists
NCT05021536 is an interventional study that assigns participants to a tested intervention. The registered 664 participants enrollment target is mid-sized for trials with a published cap, below the 891-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (25% lower).
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.
NCT05021536 names 20 study sites across 14 states, led by California, Florida, Georgia.
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.
What interventions are being tested in trial NCT05021536?
The interventions under investigation include: Placebo (OTHER), AMX0035 (DRUG).
Who is sponsoring clinical trial NCT05021536?
This trial is sponsored by Amylyx Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
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
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05021536's enrollment target sits among peer trials
664 16th of 102 higher than 87 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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