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Approved For Marketing No phase listed Expanded access

An Intermediate Size Expanded Access Protocol of AMX0035 for ALS

ClinicalTrials.gov ID: NCT05286372

Public ClinicalTrials.gov record NCT05286372. 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.

ClinicalTrials.gov public records Last synced May 8, 2026, 4:19 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Intermediate Size, Expanded Access Protocol to Provide AMX0035, a Fixed Combination of Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO), for the Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)

Study identification

NCT ID
NCT05286372
Recruitment status
Approved For Marketing
Study type
Expanded access
Phase
Not listed
Lead sponsor
Amylyx Pharmaceuticals Inc.
Industry
Enrollment
Not listed

Conditions and interventions

Interventions

  • AMX0035 Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Not listed
Last update posted
Oct 17, 2022

United States locations

U.S. sites
20
U.S. states
14
U.S. cities
17
Facility City State ZIP Site status
University of Southern California Los Angeles California 90033
The Kaiser Permanente Medical Group Oakland California 94612
Nova Southeastern University Fort Lauderdale Florida 32608
Holy Cross Health Fort Lauderdale Florida 33308
University of Florida Gainesville Florida 32608
Northwestern University Chicago Illinois 60614
University of Kansas Medical Center Kansas City Kansas 66103
The Sean M. Healey & AMG Center for ALS Massachusetts General Hospital Boston Massachusetts 02114
Mayo Clinic Rochester Minnesota 55905
Neurology Associates, P.C. / Somnos Clinical Research Lincoln Nebraska 68510
Columbia University Medical Center New York New York 10032
Duke University Medical Center Durham North Carolina 27705
University of Pennsylvania Philadelphia Pennsylvania 19104
Thomas Jefferson University Weinberg ALS Center Philadelphia Pennsylvania 19107
Texas Tech University Health Sciences Center El Paso El Paso Texas 79995
Virginia Commonwealth University Richmond Virginia 23298
Swedish Neuroscience Institute Seattle Washington 98122
University of Washington School of Medicine Seattle Washington 98195
Providence St. Luke's Rehabilitation Medical Center Spokane Washington 99202
University of Wisconsin Madison Wisconsin 53705

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 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05286372, 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 Oct 17, 2022 · 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 NCT05286372 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →