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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05178810
Other study ID # FAB122-CT-2001
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date October 18, 2021
Est. completion date June 20, 2024

Study information

Verified date January 2023
Source Ferrer Internacional S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date June 20, 2024
Est. primary completion date June 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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;

Study Design


Intervention

Drug:
FAB122
Daily dose 100 mg
Placebo
Daily dose

Locations

Country Name City State
Belgium University Hospitals Leuven Leuven
France CHRU de Lille - Hôpital Roger Salengro Lille
France CHU de Limoges - Hôpital Dupuytren Limoges
France Centre Hospitalo-Universitaire La Timone Marseille
France CHU de Montpellier Montpellier
France CHU Nice Nice
France Hôpital de la Salpêtrière Paris
France CHRU de Tours Tours
Germany Universitätsmedizin Berlin Berlin
Germany Universitätsklinikum Carl Gustav Carus Dresden
Germany Hannover Medical School Hannover
Germany Universitätsklinikum Ulm Ulm
Ireland Trinity College Dublin/Beaumont Hospital Dublin
Italy Azienda Ospedaliera Universitaria Cagliari Cagliari
Italy Centro Clinico NEMO Milan
Italy University of Milan Medical School Milan
Italy University of Torino - Rita Levi Montalcini Department of Neuroscience Milan
Italy Azienda Ospedaliero Universitaria Di Modena Modena
Italy Azienda Ospedaliera Universitaria ( A O U ) dell'Università degli studi della Campania "Luigi Vanvitelli" Napoli
Italy University of Padua - Azienda Ospedaliera di Padova Padua
Netherlands UMC Utrecht Utrecht
Poland Centrum Medyczne Neuromed Bydgoszcz
Poland Linden Medical Centre Kraków
Poland City Clinic SP. z o. o. Warsaw
Portugal Centro Hospitalar Universitário Lisboa-Norte Lisboa
Spain Hospital Universitari de Bellvitge Barcelona
Spain Hospital Universitario de Basurto Bilbao
Spain Hospital San Rafael Madrid
Spain Hospital Universitario La Paz-Carlos III Madrid
Spain Hospital Regional Universitario Málaga Málaga
Spain Hospital Clínico Universitario de Santiago de Compostela Santiago De Compostela
Spain Hospital Virgen del Rocio Sevilla
Spain Hospital Universitario y Politécnico La Fe Valencia
Sweden Karolinska Institutet Estocolmo
United Kingdom King's College London London
United Kingdom Manchester MND care centre Manchester
United Kingdom John Radcliffe Hospital Oxford
United Kingdom Sheffield Teaching Hospitals NHS Foundation Trust Sheffield

Sponsors (3)

Lead Sponsor Collaborator
Ferrer Internacional S.A. Julius Clinical, Stichting TRICALS Foundation

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Ireland,  Italy,  Netherlands,  Poland,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) The total score ranges from 48 (no limitation in daily activities) to 0 (total inability). 48 weeks
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