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HEALEY ALS Platform Trial - Master Protocol
NCT04297683 · View on ClinicalTrials.gov ↗
Study Summary
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.
Conditions Studied
Interventions
- DRUG Zilucoplan
- DRUG Verdiperstat
- DRUG CNM-Au8
- DRUG Pridopidine
- DRUG SLS-005 Trehalose
Study Locations (20)
California
- Loma Linda University Health — Loma Linda
- Kaiser Permanente Los Angeles Medical Center — Los Angeles
- University of Southern California — Los Angeles
- Cedars-Sinai Medical Center — Los Angeles
- University of California, Irvine — Orange
- Forbes Norris MDA/ALS Research Center, California Pacific Medical Center — San Francisco
- University of California, San Francisco — San Francisco
Florida
- Nova Southeastern University — Davie
- University of Florida — Gainesville
- Mayo Clinic Florida — Jacksonville
- University of Miami — Miami
- University of South Florida — Tampa
Arizona
- Barrow Neurological Institute — Phoenix
- Mayo Clinic Scottsdale — Scottsdale
Connecticut
- Hospital for Special Care — New Britain
- Yale University — New Haven
District of Columbia
- Georgetown University — Washington D.C.
- George Washington University — Washington D.C.
Arkansas
- University of Arkansas for Medical Sciences — Little Rock
Colorado
- University of Colorado — Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2020-06-14 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04297683
The ClinicalTrials.gov registry entry for NCT04297683 describes a study currently listed as recruiting. 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 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merit E. Cudkowicz, MD, which has 1 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 5 interventions — of which Zilucoplan 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: NCT04297683 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Arizona. 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 NCT04297683 about?
NCT04297683 is a clinical study titled "HEALEY ALS Platform Trial - Master Protocol". The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.
What is the current status of trial NCT04297683?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 1,500 participants. The study started on 2020-06-14. Estimated completion is 2028-08.
What conditions does trial NCT04297683 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 NCT04297683?
The interventions under investigation include: Zilucoplan (DRUG), Verdiperstat (DRUG), CNM-Au8 (DRUG), Pridopidine (DRUG), SLS-005 Trehalose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04297683?
This trial is sponsored by Merit E. Cudkowicz, MD, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04297683 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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