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NCT03127514 · ClinicalTrials.gov registry record · Phase 2
AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study, sponsored by Amylyx Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 137
- Enrollment target
NCT03127514: Completed Phase 2 study, sponsored by Amylyx Pharmaceuticals.
NCT03127514 is a Phase 2 study that has completed, run by Amylyx Pharmaceuticals. The registered enrollment target is 137 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03127514, a Phase 2 study, has completed, sponsored by Amylyx Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 137 participants
- Enrollment target
Study Summary
The CENTAUR trial was a 2:1 (active:placebo) randomized, double-blind, placebo-controlled Phase II trial to evaluate the safety and efficacy of AMX0035 for the treatment of ALS.
Primary Outcome
Change in slope of Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) over treatment duration. The ALSFRS-R consists of 12 items across 4 subdomains of function (bulbar, fine motor, gross motor, and breathing) with each item scored on a scale from 0 (total loss of function) to 4 (no loss of function). Total scores range from 0 to 48, with higher scores indicating better function.
Interventions
- OTHER Placebo
- DRUG AMX0035
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2017-06-22 |
| Est. Completion | 2019-11-24 |
| Phase | Phase 2 |
What the finished NCT03127514 record still lists
NCT03127514 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03127514 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03127514 about?
NCT03127514 is a clinical study titled "AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)". The CENTAUR trial was a 2:1 (active:placebo) randomized, double-blind, placebo-controlled Phase II trial to evaluate the safety and efficacy of AMX0035 for the treatment of ALS.
What is the current status of trial NCT03127514?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 137 participants. The study started on 2017-06-22. Estimated completion is 2019-11-24.
What interventions are being tested in trial NCT03127514?
The interventions under investigation include: Placebo (OTHER), AMX0035 (DRUG).
Who is sponsoring clinical trial NCT03127514?
This trial is sponsored by Amylyx Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03127514's enrollment target sits among peer trials
137 527th of 2000 higher than 1,474 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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