Open Label Extension Study of AMX0035 in Patients With ALS

Completed · Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis, ALS

In brief

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).

Key facts

Study ID

NCT03488524

Run by

Amylyx Pharmaceuticals Inc.

People needed

90

Starts

2018-03-29

Expected to finish

2021-03-01

Last updated by the study team

2025-08-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completion of all visits in the randomized, double blind AMX3500 study. Participants who received tracheostomy or permanent assisted ventilation (PAV) during the course of the main study could enroll in the OLE if they completed all visits in the main study.
• Must enroll in the OLE within 28 days of the Week 24 visit of the main study.
• Signed informed consent to enter the OLE phase.

You may not qualify if…

• Discontinued study drug prematurely in the double-blind phase of the study for reasons other than tracheostomy or PAV.
• Exposure to or anticipated requirement for any disallowed medication listed in the protocol.
• Any ongoing adverse events that in the opinion of the Site Investigator are clear contraindications to the study drug.
• Unstable cardiac or other life-threatening disease emergent during the randomized, double blind study
• Any major medical condition that in the opinion of the Site Investigator would interfere with the study and place the subject at increased risk.

Where it is running

• Barrow Neurological Institute-Dignity Health, St Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• University of California, Irvine — Orange, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• University of South Florida College of Medicine — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• University of Iowa, Carver College of Medicine — Iowa City, Iowa, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Ochsner Neuroscience Institute — New Orleans, Louisiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• University of Michigan, Michigan Medicine — Ann Arbor, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Washington University Medical Center — St Louis, Missouri, United States
• Neurology Associates, PC — Lincoln, Nebraska, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• The Ohio State University, Wexner Medical Center — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• The Penn Comprehensive Neuroscience Center — Philadelphia, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Texas Neurology, PA — Dallas, Texas, United States
• University of Texas Health Science Center, San Antonio — San Antonio, Texas, United States
• Swedish Neuroscience Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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