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Completed Phase 2 Interventional Results available

AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)

ClinicalTrials.gov ID: NCT03127514

Public ClinicalTrials.gov record NCT03127514. 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

Evaluation of the Safety, Tolerability, Efficacy and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for the Treatment of ALS

Study identification

NCT ID
NCT03127514
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Amylyx Pharmaceuticals Inc.
Industry
Enrollment
137 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 80 Years
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
Jun 21, 2017
Primary completion
Sep 24, 2019
Completion
Nov 23, 2019
Last update posted
May 15, 2024

2017 – 2019

United States locations

U.S. sites
25
U.S. states
20
U.S. cities
24
Facility City State ZIP Site status
Barrow Neurological Institute Phoenix Arizona 85013
UC Irvine Medical Center Orange California 92868
Forbes Norris MDA/ALS Research Center - California Pacific Medical Center San Francisco California 94114
University of Florida Medical Center Gainesville Florida 32610
Carol and Frank Morsini Center for Advanced Health Care - University of South Florida Tampa Florida 33612
Emory University Hospital Atlanta Georgia 30322
University of Iowa Hospitals and Clinics Iowa City Iowa 52242
University of Kentucky Medical Center Lexington Kentucky 40536
Ochsner Neuroscience Institute New Orleans Louisiana 70121
Johns Hopkins Hospital Baltimore Maryland 21287
Massachusetts General Hospital Boston Massachusetts 02114
University of Massachusetts Memorial Medical Center Worcester Massachusetts 01655
University of Michigan Medical Center Ann Arbor Michigan 48109
Hennepin County Medical Center Minneapolis Minnesota 55415
Washington University Medical Center St Louis Missouri 63110
Neurology Associates P.C. Lincoln Nebraska 68506
Mount Sinai Beth Israel New York New York 10003
Wake Forest Baptist Medical Center Winston-Salem North Carolina 27157
The Ohio State University Wexner Medical Center Columbus Ohio 43221
Oregon Health & Science University Portland Oregon 97239
The Penn Comprehensive ALS Center Philadelphia Pennsylvania 19107
Temple University Hospital Philadelphia Pennsylvania 19140
Texas Neurology, P.A. Dallas Texas 75214
University of Texas Health Science Center at San Antonio San Antonio Texas 78229
ALS Center at the Swedish Neuroscience Institute Seattle Washington 98122

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03127514, 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 May 15, 2024 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03127514 live on ClinicalTrials.gov.

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