Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04436497 · ClinicalTrials.gov registry record · Phase 2
HEALEY ALS Platform Trial - Regimen A Zilucoplan
A Phase 2 study, sponsored by Merit E. Cudkowicz, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 162
- Enrollment target
NCT04436497: Completed Phase 2 study, sponsored by Merit E. Cudkowicz, MD.
NCT04436497 is a Phase 2 study that has completed, run by Merit E. Cudkowicz, MD. The registered enrollment target is 162 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04436497, a Phase 2 study, has completed, sponsored by Merit E. Cudkowicz, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 162 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 A will evaluate the safety and efficacy of a single study drug, zilucoplan, 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 of 12 questions assessing distinct functional ability 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 Zilucoplan
- DRUG Matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2022-05-04 |
| Phase | Phase 2 |
What the finished NCT04436497 record still lists
NCT04436497 is an interventional study that assigns participants to a tested intervention. The registered 162 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 (22% higher).
The record links to 0 conditions, and to 2 interventions - of which Zilucoplan is the first listed.
NCT04436497 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04436497 about?
NCT04436497 is a clinical study titled "HEALEY ALS Platform Trial - Regimen A Zilucoplan". 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 A will evaluate the safety and efficacy of a single study drug, zilucoplan, in participants with ALS.
What is the current status of trial NCT04436497?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 162 participants. The study started on 2020-07-29. Estimated completion is 2022-05-04.
What interventions are being tested in trial NCT04436497?
The interventions under investigation include: Zilucoplan (DRUG), Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT04436497?
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 NCT04436497's enrollment target sits among peer trials
162 418th 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02347111 · 162 participants · Phase 4
Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation
- NCT02610426 · 162 participants
Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Congestive Heart Failure Receiving Therapy for Breast Cancer
- NCT05040711 · 162 participants · NA
mHealth Mindfulness With Patients With Serious Illness and Their Caregivers
- NCT05514717 · 162 participants · Phase 1
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI