Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
Reason given: After the analysis of the main ADORE study it is concluded that there is no clinical benefit for the patients.
Key facts
- Where
- Barcelona, SpainSee the site
- Phase
- Phase 3
Where in Spain
- Hospital Universitari de BellvitgeBarcelona, SpainNo longer taking part
Trial details
- Who runs it
- Ferrer Internacional S.A.
- Trial code
- NCT05866926
- Record updated
- 4 March 2025
- Original description
A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral SclerosisRead full original descriptionShow less
A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis
Inclusion: who completed the full study period in the main ADORE study (FAB122-CT-2001); whom the investigator has no concern and judges tolerable for initiating or continuing treatment with FAB122 from a risk and benefit point of view; 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; 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: 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; Patient who discontinued study drug prematurely in the double-blind phase of the study (ADORE Study) for safety reasons; 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.