Abstract Details

Title Study Design for a Phase 3, Multicenter, Open-Label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Patients with ALS (MT-1186-A03)

Topic Neuromuscular and Clinical Neurophysiology (EMG)

Presentation(s) P2 - Poster Session 2 (11:45 AM-12:45 PM)

Poster/Presentation
Number 11-008

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

Background 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.

Design/Methods

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.

Results Ongoing.

Conclusions

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.

Authors/Disclosures
Alejandro Salah, MD, PhD, MBA, MHA PRESENTER	Dr. Salah has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma.
Daniel Selness (Mitsubishi Tanabe Pharma America, Inc)	Mr. Selness has received personal compensation for serving as an employee of Mitsubishi Tanabe.
	No disclosure on file
Takeshi Sakata	Takeshi Sakata has received personal compensation for serving as an employee of Mitsubishi Tanabe.
Stephen Apple	Stephen Apple has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma America, Inc.

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