Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis

PHASE3CompletedINTERVENTIONAL
Enrollment

313

Participants

Timeline

Start Date

October 18, 2021

Primary Completion Date

October 26, 2023

Study Completion Date

October 26, 2023

Conditions
Amyotrophic Lateral Sclerosis
Interventions
DRUG

FAB122

Daily dose 100 mg

DRUG

Placebo

Daily dose

Trial Locations (38)

Unknown

University Hospitals Leuven, Leuven

CHRU de Lille - Hôpital Roger Salengro, Lille

CHU de Limoges - Hôpital Dupuytren, Limoges

Centre Hospitalo-Universitaire La Timone, Marseille

CHU de Montpellier, Montpellier

CHU Nice, Nice

Hôpital de la Salpêtrière, Paris

CHRU de Tours, Tours

Universitätsmedizin Berlin, Berlin

Universitätsklinikum Carl Gustav Carus, Dresden

Hannover Medical School, Hanover

Universitätsklinikum Ulm, Ulm

Trinity College Dublin/Beaumont Hospital, Dublin

Azienda Ospedaliera Universitaria Cagliari, Cagliari

Centro Clinico NEMO, Milan

University of Milan Medical School, Milan

University of Torino - Rita Levi Montalcini Department of Neuroscience, Milan

Azienda Ospedaliero Universitaria Di Modena, Modena

"Azienda Ospedaliera Universitaria ( A O U ) dell'Università degli studi della Campania Luigi Vanvitelli", Napoli

University of Padua - Azienda Ospedaliera di Padova, Padua

UMC Utrecht, Utrecht

Centrum Medyczne Neuromed, Bydgoszcz

Linden Medical Centre, Krakow

City Clinic SP. z o. o., Warsaw

Centro Hospitalar Universitário Lisboa-Norte, Lisbon

Hospital Universitari de Bellvitge, Barcelona

Hospital Universitario de Basurto, Bilbao

Hospital San Rafael, Madrid

Hospital Universitario La Paz-Carlos III, Madrid

Hospital Regional Universitario Málaga, Málaga

Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela

Hospital Virgen del Rocio, Seville

Hospital Universitario y Politécnico La Fe, Valencia

Karolinska Institutet, Stockholm

King's College London, London

Manchester MND care centre, Manchester

John Radcliffe Hospital, Oxford

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Julius Clinical

INDUSTRY

collaborator

Stichting TRICALS Foundation

OTHER

lead

Ferrer Internacional S.A.

INDUSTRY

NCT05178810 - Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis | Biotech Hunter | Biotech Hunter