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NCT04297683 · ClinicalTrials.gov registry record · Phase 2
HEALEY ALS Platform Trial - Master Protocol
A Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by Merit E. Cudkowicz, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 1,500
- Enrollment target
- 20
- Study locations
NCT04297683: Recruiting Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by Merit E. Cudkowicz, MD.
NCT04297683 is a Phase 2 study of Amyotrophic Lateral Sclerosis that is actively recruiting participants, run by Merit E. Cudkowicz, MD. The registered enrollment target is 1,500 participants, above the 883-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (70% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04297683, a Phase 2 study of Amyotrophic Lateral Sclerosis, is actively recruiting participants, sponsored by Merit E. Cudkowicz, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 1,500 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Change in disease severity as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) total score and survival.
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 |
What NCT04297683 shows while recruiting
NCT04297683 is an interventional study that assigns participants to a tested intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, above the 883-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (70% higher).
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.
NCT04297683 names 20 study sites across 7 states, led by California, Florida, Arizona.
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.
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).
Who is sponsoring clinical trial NCT04297683?
This trial is sponsored by Merit E. Cudkowicz, MD, which has 8 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT04297683's enrollment target sits among peer trials
1,500 9th of 102 higher than 94 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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