Mitsubishi Tanabe Pharma America, Inc.  today announced it has completed enrollment for the global, multi-center, double-blind, Phase 3b study  evaluating the long-term efficacy and safety of two dosing regimens of RADICAVA ORS® in people with amyotrophic lateral sclerosis over 48 weeks. This study is the postmarketing commitment following the U.S. Food and Drug Administration (FDA) approval of intravenous (IV) RADICAVA® (edaravone). Topline results of the study are anticipated in 2024.

"We're very pleased to announce the completion of trial enrollment in our Phase 3b study of RADICAVA ORS, representing an important achievement in our ongoing commitment to the fight against ALS," said Atsushi Fujimoto, President, MTPA. "We are deeply grateful to the study participants and their families, as well as study investigators and clinical staff for working so diligently to help us meet this milestone."

Study MT-1186-A02, which enrolled 384 people with ALS across 80 sites in the U.S., 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.1 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.

"We look forward to seeing how the results of this study evaluating an alternative dosing regimen for RADICAVA ORS build upon our existing data to support its long-term efficacy and safety profile for people living with ALS, and how it may increase our understanding of the full potential of the medication as a treatment option," said primary investigator Michael D. Weiss, M.D., FAAN, University of Washington Medical Center.

In prior clinical trials for RADICAVA, the most common adverse events (AEs) reported in participants were contusion (15%), gait disturbance (13%) and headache (10%).1 In the pivotal safety trial for RADICAVA ORS, the most common AEs reported at 24 weeks in participants were muscular weakness (16.2%), fall (15.7%) and fatigue (7.6%). RADICAVA and RADICAVA ORS are contraindicated in people with a history of hypersensitivity to edaravone or any of the inactive ingredients.1 See Important Safety Information below. Safety and efficacy data from Study MT-1186-A02 have not yet been analyzed.

 

Source:prnewswire.com

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