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NCT03488524 · ClinicalTrials.gov registry record · Phase 2
Open Label Extension Study of AMX0035 in Patients With ALS
A Phase 2 study of Amyotrophic Lateral Sclerosis and ALS, sponsored by Amylyx Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT03488524: Completed Phase 2 study of Amyotrophic Lateral Sclerosis and ALS, sponsored by Amylyx Pharmaceuticals.
NCT03488524 is a Phase 2 study of Amyotrophic Lateral Sclerosis and ALS that has completed, run by Amylyx Pharmaceuticals. The registered enrollment target is 90 participants, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03488524, a Phase 2 study of Amyotrophic Lateral Sclerosis and ALS, has completed, sponsored by Amylyx Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
Study Summary
This extension study, in which all participants received active treatment (AMX0035), was designed to assess the longer-term safety and therapeutic potential of AMX0035 for participants who have completed the Main Study (AMX3500, also known as CENTAUR).
Primary Outcome
Number of participants with TEAEs from baseline in the OLE study through the last participant's last visit in the OLE
Conditions Studied
Interventions
- DRUG AMX0035
Study Locations (20)
California
- University of California, Irvine - Orange
- California Pacific Medical Center - San Francisco
Florida
- University of Florida College of Medicine - Gainesville
- University of South Florida College of Medicine - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
- University of Massachusetts Memorial Medical Center - Worcester
Arizona
- Barrow Neurological Institute-Dignity Health, St Joseph's Hospital and Medical Center - Phoenix
Georgia
- Emory University Hospital - Atlanta
Iowa
- University of Iowa, Carver College of Medicine - Iowa City
Kentucky
- University of Kentucky Medical Center - Lexington
Louisiana
- Ochsner Neuroscience Institute - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2018-03-29 |
| Est. Completion | 2021-03-01 |
| Phase | Phase 2 |
What the finished NCT03488524 record still lists
NCT03488524 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 897-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which AMX0035 is the first listed.
NCT03488524 names 20 study sites across 17 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03488524 about?
NCT03488524 is a clinical study titled "Open Label Extension Study of AMX0035 in Patients With ALS". This extension study, in which all participants received active treatment (AMX0035), was designed to assess the longer-term safety and therapeutic potential of AMX0035 for participants who have completed the Main Study (AMX3500, also known as CENTAUR).
What is the current status of trial NCT03488524?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2018-03-29. Estimated completion is 2021-03-01.
What conditions does trial NCT03488524 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis, ALS.
What interventions are being tested in trial NCT03488524?
The interventions under investigation include: AMX0035 (DRUG).
Who is sponsoring clinical trial NCT03488524?
This trial is sponsored by Amylyx Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03488524 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Iowa. 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 NCT03488524's enrollment target sits among peer trials
90 42nd of 102 higher than 60 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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