At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 313 enrolled
Drug / intervention
FAB122 +1 moredrug
Likely dose
FAB122 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
In Brief
A Phase 3 clinical trial evaluating FAB122 and Placebo for Amyotrophic Lateral Sclerosis. Completed, enrolled 313 participants across 38 sites in 11 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis
CountriesBelgium, France, Germany, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, United Kingdom
CollaboratorsJulius Clinical, Stichting TRICALS Foundation
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartOct 2021
First PostedJan 2022
Primary CompletionOct 2023
TodayJul 2026
First PostedJan 5, 2022
Enrollment StartOct 18, 2021
Primary CompletionOct 26, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.5 years ago
Interventions
FAB122drug
Daily dose 100 mg
Placebodrug
Daily dose