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NCT04248465 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Ravulizumab in ALS Participants
A Phase 3 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 382
- Enrollment target
NCT04248465: Clinical Trial Phase 3 study, sponsored by Alexion Pharmaceuticals.
NCT04248465 is a Phase 3 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 382 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04248465, a Phase 3 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 382 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.
Primary Outcome
The ALSFRS-Revised is a validated instrument for evaluating the levels of the functional status of participants with amyotrophic lateral sclerosis (ALS) in 4 areas, including bulbar, gross motor activity, fine motor activity, and respiratory functions. The scale included 12 functional items and each item is rated on a 0 to 4 scale, with a maximum total score of 48. A higher score indicated greater retention of function. Baseline was defined as last non-missing value on or before first study drug
Interventions
- DRUG Placebo
- BIOLOGICAL Ravulizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2020-03-30 |
| Est. Completion | 2021-10-17 |
| Phase | Phase 3 |
Why NCT04248465 stopped before completion
NCT04248465 is an interventional study that assigns participants to a tested intervention. The registered 382 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04248465 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04248465 about?
NCT04248465 is a clinical study titled "An Efficacy and Safety Study of Ravulizumab in ALS Participants". The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.
What is the current status of trial NCT04248465?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 382 participants. The study started on 2020-03-30. Estimated completion is 2021-10-17.
What interventions are being tested in trial NCT04248465?
The interventions under investigation include: Placebo (DRUG), Ravulizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04248465?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04248465's enrollment target sits among peer trials
382 978th of 2000 higher than 1,019 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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