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NCT04516096 · ClinicalTrials.gov registry record · Phase 2
A Compassionate Use Protocol of AMX0035 for Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by Amylyx Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 5
- Study locations
NCT04516096: Completed Phase 2 study of Amyotrophic Lateral Sclerosis, sponsored by Amylyx Pharmaceuticals.
NCT04516096 is a Phase 2 study of Amyotrophic Lateral Sclerosis that has completed, run by Amylyx Pharmaceuticals. The registered enrollment target is 28 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04516096, a Phase 2 study of Amyotrophic Lateral Sclerosis, has completed, sponsored by Amylyx Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 5
- Study locations
Study Summary
The protocol is intended to provide extended treatment with AMX0035 to patients who previously participated in an Amylyx sponsored study of AMX0035 for ALS.
Primary Outcome
Rate of treatment emergent adverse events during AMX0035 therapy
Conditions Studied
Interventions
- DRUG AMX0035
Study Locations (5)
Massachusetts
- Massachusetts General Hospital - Boston
- University of Massachusetts Memorial Medical Center - Worcester
California
- Forbes Norris MDA/ALS Research Center - California Pacific Medical Center - San Francisco
Michigan
- University of Michigan Medical Center - Ann Arbor
North Carolina
- Wake Forest Baptist Medical Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-11-22 |
| Est. Completion | 2023-01-31 |
| Phase | Phase 2 |
What the finished NCT04516096 record still lists
NCT04516096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which AMX0035 is the first listed.
NCT04516096 lists 5 locations in 4 states (Massachusetts, California, Michigan).
Frequently Asked Questions
What is clinical trial NCT04516096 about?
NCT04516096 is a clinical study titled "A Compassionate Use Protocol of AMX0035 for Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS)". The protocol is intended to provide extended treatment with AMX0035 to patients who previously participated in an Amylyx sponsored study of AMX0035 for ALS.
What is the current status of trial NCT04516096?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2020-11-22. Estimated completion is 2023-01-31.
What conditions does trial NCT04516096 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT04516096?
The interventions under investigation include: AMX0035 (DRUG).
Who is sponsoring clinical trial NCT04516096?
This trial is sponsored by Amylyx Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04516096 being conducted?
This trial has 5 study locations across California, Massachusetts, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04516096's enrollment target sits among peer trials
28 66th of 102 higher than 35 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis 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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Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS
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