Open Label Extension Study of AMX0035 in Patients With ALS
Public ClinicalTrials.gov record NCT03488524. 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
Evaluation of the Safety, Tolerability, Efficacy, and Activity of AMX0035, a Fixed Combination of Phenylbutyrate (PB) and Tauroursodeoxycholic Acid (TUDCA), for Treatment of Amyotrophic Lateral Sclerosis: Open-Label Extension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This extension study, in which all participants received active treatment (AMX0035), was designed to assess the longer-term safety and therapeutic potential of AMX0035 for participants who have completed the Main Study (AMX3500, also known as CENTAUR).
Study identification
- NCT ID
- NCT03488524
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- 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
- Mar 29, 2018 (Actual)
- Primary completion
- Mar 1, 2021 (Actual)
- Completion
- Mar 1, 2021 (Actual)
- Last update posted
- Aug 13, 2025
2018 – 2021
United States locations
- U.S. sites
- 24
- U.S. states
- 19
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barrow Neurological Institute-Dignity Health, St Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| University of California, Irvine | Orange | California | 92868 | — |
| California Pacific Medical Center | San Francisco | California | 94114 | — |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | — |
| University of South Florida College of Medicine | Tampa | Florida | 33612 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| University of Iowa, Carver College of Medicine | Iowa City | Iowa | 52242 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | — |
| Ochsner Neuroscience Institute | New Orleans | Louisiana | 70121 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| University of Michigan, Michigan Medicine | Ann Arbor | Michigan | 48109 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| Washington University Medical Center | St Louis | Missouri | 63110 | — |
| Neurology Associates, PC | Lincoln | Nebraska | 68506 | — |
| Wake Forest School of Medicine | 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 Neuroscience Center | Philadelphia | Pennsylvania | 19107 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| Texas Neurology, PA | Dallas | Texas | 75214 | — |
| University of Texas Health Science Center, San Antonio | San Antonio | Texas | 78229 | — |
| Swedish Neuroscience Center | 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 NCT03488524, 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, 2025 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03488524 live on ClinicalTrials.gov.