Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

664

Participants

Timeline

Start Date

October 28, 2021

Primary Completion Date

January 19, 2024

Study Completion Date

January 1, 2026

Conditions
Amyotrophic Lateral Sclerosis
Interventions
OTHER

Placebo

Matching Placebo Comparator

DRUG

AMX0035

Proprietary formulation of taurursodiol and sodium phenylbutyrate

Trial Locations (69)

10032

Columbia University, New York

19107

University of Pennsylvania, Philadelphia

19140

Lewis Katz School of Medicine at Temple University, Philadelphia

21287

Johns Hopkins University School of Medicine Outpatient Center, Baltimore

23233

Virginia Commonwealth University, Henrico

27109

Wake Forest University Health Sciences, Winston-Salem

27514

University of North Carolina at Chapel Hill, Chapel Hill

30322

Emory University, Atlanta

30912

Augusta University Neuroscience Center, Augusta

32068

University of Florida, Gainesville

33612

University of South Florida, Tampa

43210

The Ohio State University, Columbus

55415

Hennepin Healthcare Research Institute, Minneapolis

60611

Northwestern University, Chicago

63110

Washington University School of Medicine, St Louis

68510

Somnos Clinical Research, Lincoln

72506

Texas Neurology, Dallas

78756

Austin Neuromuscular Center, Austin

80045

University of Colorado, Aurora

85013

Barrow Neurological Institute, Phoenix

90033

University of Southern California, Los Angeles

92868

University of California Irvine, Orange

94109

California Pacific Medical Center Research Institute, San Francisco

98122

Swedish Neuroscience Institute, Seattle

98195

University of Washington, Seattle

02114

Healey & AMG Center for ALS Research at Massachusetts General Hospital, Boston

01655

University of Massachusetts, Worcester

08901

Rutgers University, New Brunswick

Unknown

University Hospitals Leuven, Leuven

Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer Cellule Mutualisée de Recherche Clinique (CMRC), Bron

Hopital Gabriel Montpied Service de Neurologie, Clermont-Ferrand

CHRU de Lille - Hôpital Roger Salengro, Lille

CHU de Limoges - Hôpital Dupuytren, Limoges

Hôpitaux Universitaires de Marseille Timone, Marseille

CHU de Montpellier, Montpellier

CHU Nice, Nice

Hôpital de la Salpêtrière, Paris

Le Centre Hospitalier Régional Universitaire de Tours, Tours

Charité - Universitätsmedizin Berlin, Berlin

Uniklinikum Dresden, Dresden

Hannover Medical School, Hanover

Jena University Hospital, Jena

Medizinische Fakultät Mannheim der Universität Heidelberg, Mannheim

University Medical Center Rostock, Rostock

Ulm University Medical Centre, Ulm

Trinity College Dublin/Beaumont Hospital, Dublin

Università degli Studi di Bari Aldo Moro, Bari

Centro Clinico NEMO, Milan

University of Milan Medical School, Milan

Azienda Ospedaliero Universitaria Di Modena, Modena

Università degli Studi della Campania Luigi Vanvitelli, Napoli

University of Padua, Padua

University of Torino, Turin

University Medical Center Utrecht, Utrecht

Centrum Medyczne Linden, Krakow

City Clinic Warsaw, Warsaw

Centro Hospitalar Universitário Lisboa-Norte, Lisbon

Hospital del Mar, Barcelona

Hospital Universitari de Bellvitge-IDIBELL, Barcelona

Hospital San Rafael, Madrid

Biodonostia Health Research Institute; Hospital Universitario Donostia, San Sebastián

Hospital Universitario y Politécnico La Fe, Valencia

Karolinska Institutet, Stockholm

Umeå University Hospital, Umeå

King's College London, London

UCL Queen Square Institute of Neurology, London

University of Plymouth, Plymouth

Salford Royal Hospital Barnes, Salford

Sheffield Institute for Translational Neuroscience (SITraN), Sheffield

Sponsors
All Listed Sponsors
lead

Amylyx Pharmaceuticals Inc.

INDUSTRY