To assess the continued long-term safety and tolerability of oral edaravone in patients with amyotrophic lateral sclerosis (ALS).

Radicava® (edaravone injection) is a US Food and Drug Administration–approved treatment for ALS that slows the rate of physical functional decline. There is interest in a non-intravenous formulation of edaravone. An ongoing phase 3 study (MT-1186-A01) is currently assessing the safety and tolerability of an investigational oral formulation of edaravone (MT-1186) with a treatment period of 48 weeks.

Study MT-1186-A03 is a long-term safety and tolerability extension study for patients who complete MT-1186-A01. Patients who meet the enrollment criteria will be enrolled into the MT-1186-A03 study and will continue to receive oral edaravone without interruption for an additional treatment period of 96 weeks, resulting in a total treatment duration of nearly 3 years with oral edaravone.  

Patients will continue to receive a 105-mg dose of MT-1186 administered in treatment cycles that replicate the dosing of intravenous edaravone. In addition to the primary safety analysis, Study MT-1186-A03 also includes exploratory end points, such as change from baseline in the revised ALS Functional Rating Scale (ALSFRS-R) score and time to death, tracheostomy, or permanent assisted mechanical ventilation.

It is anticipated that Study MT-1186-A03 will include approximately 130 patients.

Ongoing.

This extension study of oral edaravone will provide important information on the continued long-term safety and tolerability of this new formulation of edaravone in patients with ALS.