A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis

FAB122-CT-2201

A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis

2023-03-06

2024-01-09

2024-02-22

Terminated

Early phase I

206

Inclusion Criteria: 1. who completed the full study period in the main ADORE study (FAB122-CT-2001); 2. whom the investigator has no concern and judges tolerable for initiating or continuing treatment with FAB122 from a risk and benefit point of view; 3. a female subject should not be able to become pregnant up to 30 days after the last dose of FAB122 and needs to meet at least one of the following criteria: * female who is of reproductive potential and has a negative pregnancy test at baseline and is non-lactating. * female subject who is not of reproductive potential is eligible without requiring the use of contraception 4. a male patient must: * agree he will not donate sperm during the period he will be using FAB122, AND use a condom during sexual intercourse with pregnant or non-pregnant women of childbearing potential Exclusion Criteria: 1. Patient who has a medical condition or personal circumstances which, in the opinion of the investigator, will make initiation or continuation of treatment with FAB122 not tolerable for them from a risk and benefit point of view. 2. Patient who discontinued study drug prematurely in the double-blind phase of the study (ADORE Study) for safety reasons. 3. Patient who has received any other investigational drug within the period between last visit of the main study and first visit of the extension study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 206, 'type': 'ACTUAL'}}

2024-02-28