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NCT04414345 · ClinicalTrials.gov registry record · Phase 2
HEALEY ALS Platform Trial - Regimen C CNM-Au8
A Phase 2 study, sponsored by Merit E. Cudkowicz, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 161
- Enrollment target
NCT04414345: Completed Phase 2 study, sponsored by Merit E. Cudkowicz, MD.
NCT04414345 is a Phase 2 study that has completed, run by Merit E. Cudkowicz, MD. The registered enrollment target is 161 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04414345, a Phase 2 study, has completed, sponsored by Merit E. Cudkowicz, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 161 participants
- Enrollment target
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. Regimen C will evaluate the safety and efficacy of a single study drug, CNM-Au8, in participants with ALS.
Primary Outcome
Change in disease severity as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) total score using a Bayesian repeated measures model that accounts for loss to follow-up due to mortality. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
Interventions
- DRUG Matching Placebo
- DRUG CNM-Au8
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2020-07-30 |
| Est. Completion | 2023-03-07 |
| Phase | Phase 2 |
What the finished NCT04414345 record still lists
NCT04414345 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% higher).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT04414345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04414345 about?
NCT04414345 is a clinical study titled "HEALEY ALS Platform Trial - Regimen C CNM-Au8". 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. Regimen C will evaluate the safety and efficacy of a single study drug, CNM-Au8, in participants with ALS.
What is the current status of trial NCT04414345?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 161 participants. The study started on 2020-07-30. Estimated completion is 2023-03-07.
What interventions are being tested in trial NCT04414345?
The interventions under investigation include: Matching Placebo (DRUG), CNM-Au8 (DRUG).
Who is sponsoring clinical trial NCT04414345?
This trial is sponsored by Merit E. Cudkowicz, MD, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04414345's enrollment target sits among peer trials
161 422nd of 2000 higher than 1,579 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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