Mitsubishi Tanabe Pharma America, Inc. (MTPA), a wholly-owned subsidiary of Jaan-based Mitsubishi Tanabe Pharma Corporation's (MTPC) 100% owned US holding company, Mitsubishi Tanabe Pharma Holdings America, Inc., announced on Thursday that it has completed enrolment for the global, multi-centre, double-blind, Phase 3b study (MT-1186-A02) evaluating the long-term efficacy and safety of two dosing regimens of RADICAVA ORS (edaravone) in people with amyotrophic lateral sclerosis (ALS) over 48 weeks.

This study is the post-marketing commitment following the US Food and Drug Administration (FDA) approval of intravenous (IV) RADICAVA (edaravone). Topline results of the study are anticipated in 2024.

Study MT-1186-A02, which enrolled 384 people with ALS across 80 sites in the US, Canada, Europe and Asia, will compare two dosing regimens for RADICAVA ORS over 48 weeks of treatment. After a screening period of eight weeks, study participants (18 to 75 years of age) will receive RADICAVA ORS either once-daily or following the FDA-approved on/off dosing regimen administered in 28-day cycles. The primary endpoint will measure change in ALS Functional Rating Scale-Revised (ALSFRS-R) score from baseline to week 48 of treatment.

Key secondary endpoints for the study include the change from baseline in percent-predicted slow vital capacity (SVC) and the change from baseline in the ALS Assessment Questionnaire (ALSAQ-40) at 48 weeks, as well as the time to death, tracheostomy or permanent assisted mechanical ventilation. Other secondary endpoints include the change from screening and baseline in percent-predicted forced vital capacity (FVC) at 24 and 48 weeks.