Adults 18 to 80, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Experiencing Treatment Emergent Adverse EventsPrimary· approximately 44 weeks
To evaluate the long-term safety of FAB122 in patients with ALS by assessing Number of Participants experiencing Treatment Emergent Adverse Events, evaluating nature and severity.
The study duration for these subjects, and therefore the duration of FAB122 treatment, was variable depending on the subject's start date, ranging from 3 to approximately 44 weeks.
Any TEAE
Group
Value
95% CI
FAB122
77
Placebo
41
Any Serious AE
Group
Value
95% CI
FAB122
29
Placebo
15
Any Serious TEAE
Group
Value
95% CI
FAB122
29
Placebo
15
Any TEAE leading to treatment discontinuation
Group
Value
95% CI
FAB122
7
Placebo
5
Any AE leading to death
Group
Value
95% CI
FAB122
16
Placebo
9
TEAE by relationship - Unrelated
Group
Value
95% CI
FAB122
75
Placebo
40
TEAE by relationship - Related
Group
Value
95% CI
FAB122
6
Placebo
3
TEAE by Severity - Mild
Group
Value
95% CI
FAB122
52
Placebo
31
The Secondary Efficacy Objective to Evaluate the Effect of Treatment With FAB122 Based on Change From Baseline in ALSFRS-R Until End of StudySecondary· 45 weeks
Change from baseline in ALSFRS-R total score until the end of the study. Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), Maximum value is 48 points and represents better outcome. Minimum value is 0 and represents worse outcome.
Group
Value
95% CI
FAB122
-4.4
± 4.8
Placebo
-3.8
± 5
Adverse events — posted to ClinicalTrials.gov
Time frame: 45 weeks.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT05178810 — Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Scler
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ferrer Internacional S.A.
Last refreshed: 4 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05866926.