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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04516096
The ClinicalTrials.gov registry entry for NCT04516096 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (97% lower). The listed sponsor is Amylyx Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.