Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment
Public ClinicalTrials.gov record NCT05021536. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)
Study identification
- NCT ID
- NCT05021536
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Amylyx Pharmaceuticals Inc.
- Industry
- Enrollment
- 664 participants
Conditions and interventions
Conditions
Interventions
- AMX0035 Drug
- Placebo Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 27, 2021
- Primary completion
- Jan 18, 2024
- Completion
- Dec 31, 2025
- Last update posted
- Aug 13, 2024
2021 – 2026
United States locations
- U.S. sites
- 28
- U.S. states
- 19
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| University of California Irvine | Orange | California | 92868 | — |
| California Pacific Medical Center Research Institute | San Francisco | California | 94109 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| University of Florida | Gainesville | Florida | 32068 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Augusta University Neuroscience Center | Augusta | Georgia | 30912 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Johns Hopkins University School of Medicine Outpatient Center | Baltimore | Maryland | 21287 | — |
| Healey & AMG Center for ALS Research at Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Massachusetts | Worcester | Massachusetts | 01655 | — |
| Hennepin Healthcare Research Institute | Minneapolis | Minnesota | 55415 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Somnos Clinical Research | Lincoln | Nebraska | 68510 | — |
| Rutgers University | New Brunswick | New Jersey | 08901 | — |
| Columbia University | New York | New York | 10032 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27109 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | — |
| Lewis Katz School of Medicine at Temple University | Philadelphia | Pennsylvania | 19140 | — |
| Austin Neuromuscular Center | Austin | Texas | 78756 | — |
| Texas Neurology | Dallas | Texas | 72506 | — |
| Virginia Commonwealth University | Henrico | Virginia | 23233 | — |
| Swedish Neuroscience Institute | Seattle | Washington | 98122 | — |
| University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05021536, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2024 · Synced May 8, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05021536 live on ClinicalTrials.gov.