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NCT05740813 · ClinicalTrials.gov registry record · Phase 2
HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262
A Phase 2 study, sponsored by Merit E. Cudkowicz, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 310
- Enrollment target
NCT05740813: Completed Phase 2 study, sponsored by Merit E. Cudkowicz, MD.
NCT05740813 is a Phase 2 study that has completed, run by Merit E. Cudkowicz, MD. The registered enrollment target is 310 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (133% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05740813, a Phase 2 study, has completed, sponsored by Merit E. Cudkowicz, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 310 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 F will evaluate the safety and efficacy of a single study drug, ABBV-CLS-7262, 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. Participants with higher scores have more physical function. Note that only participants who survived to their Week 24 visit contrib
Interventions
- DRUG Matching Placebo
- DRUG ABBV-CLS-7262 Dose 1
- DRUG ABBV-CLS-7262 Dose 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2023-03-23 |
| Est. Completion | 2024-10-03 |
| Phase | Phase 2 |
What the finished NCT05740813 record still lists
NCT05740813 is an interventional study that assigns participants to a tested intervention. The registered 310 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 (133% higher).
The record links to 0 conditions, and to 3 interventions - of which Matching Placebo is the first listed.
NCT05740813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05740813 about?
NCT05740813 is a clinical study titled "HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262". 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 F will evaluate the safety and efficacy of a single study drug, ABBV-CLS-7262, in participants with ALS.
What is the current status of trial NCT05740813?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 310 participants. The study started on 2023-03-23. Estimated completion is 2024-10-03.
What interventions are being tested in trial NCT05740813?
The interventions under investigation include: Matching Placebo (DRUG), ABBV-CLS-7262 Dose 1 (DRUG), ABBV-CLS-7262 Dose 2 (DRUG).
Who is sponsoring clinical trial NCT05740813?
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 NCT05740813's enrollment target sits among peer trials
310 162nd of 2000 higher than 1,838 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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