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Open Label Extension Study of AMX0035 in Patients With ALS
NCT03488524 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03488524
The ClinicalTrials.gov registry entry for NCT03488524 describes a study currently listed as completed. It is categorized as Phase 2, 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 90 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 2 conditions, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention — of which AMX0035 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: NCT03488524 reports 20 study locations spanning 17 distinct geographic areas — top geographies include California, Florida, Massachusetts. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03488524?
The interventions under investigation include: AMX0035 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03488524?
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 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.
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