Study Purpose:
Multicenter, multinational, double-blind, randomized (2:1), placebo-controlled Phase III study to investigate the efficacy and safety of 100 mg FAB122 once daily as oral formulation in ALS patients.Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
FAB122, Placebo
Placebo:
Yes
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Ferrer MedInfo / email hidden; JavaScript is required / +34 609 850 565
Study Sponsor:
Ferrer Internacional S.A.
Estimated Enrollment:
300
Estimated Study Start Date:
10 / 18 / 2021
Estimated Study Completion Date:
06 / 20 / 2024
Posting Last Modified Date:
10 / 13 / 2022
Date Study Added to neals.org:
01 / 05 / 2022
Minimum Age:
18 Years
Maximum Age:
80 Years
Main Inclusion Criteria:- Age 18 - 80 years (both inclusive), male or female;
- Diagnosis of definite, probable, probable laboratory supported or possible ALS as based on the El Escorial and the revised Airlie House diagnostic criteria for ALS;
- Onset of first symptoms* no longer than 24 months prior to randomization;
*Date of onset is the date the patient reported one or more of the following symptoms:
- Muscle weakness in limbs
- Speech/swallowing difficulties
- Respiratory symptoms: dyspnea was noticed
- SVC equal to or more than 70% of the predicted normal value for gender, height and age at screening visit;
- Change in ALSFRS-R score between 0.35 points and 1.5 points per month (both inclusive) in the period from onset of first symptoms to the Screening visit;
- Capable of providing informed consent and complying with trial procedures.
Main Exclusion Criteria:
- Diagnosis of Primary Lateral Sclerosis;
- Diagnosis of Frontotemporal Dementia;
- Diagnosis of other neurodegenerative diseases (e.g. Parkinson disease, Alzheimer disease);
- Diagnosis of polyneuropathy;
- Other causes of neuromuscular weakness;
- Have a significant pulmonary disorder not attributed to ALS and/or require treatment interfering with the evaluation of ALS on respiratory function;
- Use of intravenous (IV) edaravone within 6 months of the screening visit;
- Depend on mechanical ventilation (invasive or non-invasive) or require tracheostomy at Screening;
- Renal impairment as indicated by a creatinine clearance of less than 50 mL/min as calculated by the Cockcroft Gault equation;
- Subject has a history of clinically significant hepatic disease, hepatitis or biliary tract disease, or subject has a positive screening test for HIV, hepatitis B or C;
University Hospitals Leuven | Recruiting
Philip Van Damme
Leuven
Belgium
CHU de Limoges - Hôpital Dupuytren | Recruiting
Phillippe Couratier
Limoges
France
Centre Hospitalo-Universitaire La Timone | Recruiting
Shahram Attarian
Marseille
France
CHU de Montpellier | Recruiting
Elisa De La Cruz
Montpellier
France
CHU Nice | Recruiting
Marie-Helene Soriani
Nice
France
Hôpital de la Salpêtrière | Recruiting
Francois Salachas
Paris
France
CHRU de Tours | Recruiting
Philippe Corcia
Tours
France
CHRU de Lille - Hôpital Roger Salengro | Recruiting
Véronique Danel Brunaud
Lille
France
Universitätsmedizin Berlin | Recruiting
Thomas Meyer
Berlin
Germany
Universitätsklinikum Carl Gustav Carus | Recruiting
René Gunther
Dresden
Germany
Hannover Medical School | Recruiting
Susanne Petri
Hannover
Germany
Universitätsklinikum Ulm | Recruiting
Albert Ludolph
Ulm
Germany
Trinity College Dublin/Beaumont Hospital | Recruiting
Orla Hardiman
Dublin
Ireland
Azienda Ospedaliero Universitaria Di Modena | Recruiting
Jessica Mandrioli
Modena
Italy
Azienda Ospedaliera Universitaria ( A O U ) dell'Università degli studi della Campania "Luigi Vanvitelli" | Recruiting
Francesca Trojsi
Napoli
Italy
University of Padua - Azienda Ospedaliera di Padova | Recruiting
Gianni Soraru
Padua
Italy
University of Torino - Rita Levi Montalcini Department of Neuroscience | Recruiting
Andrea Calvo
Milan
Italy
Centro Clinico NEMO | Recruiting
Valeria Sansone
Milan
Italy
Azienda Ospedaliera Universitaria Cagliari | Recruiting
Giuseppe Borghero
Cagliari
Italy
University of Milan Medical School | Recruiting
Vincenzo Silani
Milan
Italy
UMC Utrecht | Recruiting
Leonard van den Berg
Utrecht
Netherlands
Centrum Medyczne Neuromed | Recruiting
Pawel Lisewski
Bydgoszcz
Poland
Linden Medical Centre | Recruiting
Jakub Antczak
Kraków
Poland
City Clinic SP. z o. o. | Recruiting
Magdalena Kuzma-Kozakiewicz
Warsaw
Poland
Centro Hospitalar Universitário Lisboa-Norte | Recruiting
Mamede De Carvalho
Lisboa
Portugal
Hospital Clínico Universitario de Santiago de Compostela | Recruiting
Julio Pardo Fernandez
Santiago De Compostela
Spain
Hospital Universitario y Politécnico La Fe | Recruiting
Juan Francisco Vázquez Costa
Valencia
Spain
Hospital Virgen del Rocio | Recruiting
Carmen Paradas
Sevilla
Spain
Hospital San Rafael | Recruiting
Jesus Mora
Madrid
Spain
Hospital Regional Universitario Málaga | Recruiting
Virginia Reyes Garrido
Málaga
Spain
Hospital Universitario La Paz-Carlos III | Recruiting
Javier Mascias
Madrid
Spain
Hospital Universitario de Basurto | Recruiting
Luis Varona
Bilbao
Spain
Hospital Universitari de Bellvitge | Recruiting
Monica Povedano
Barcelona
Spain
Karolinska Institutet | Recruiting
Caroline Ingre
Estocolmo
Sweden
King's College London | Recruiting
Ammar Al-Chalabi
London
United Kingdom
Manchester MND care centre | Recruiting
John Ealing
Manchester
United Kingdom
John Radcliffe Hospital | Recruiting
Martin Turner
Oxford
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust | Recruiting
Christopher McDermott
Sheffield
United Kingdom