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Abstract Details

Phase 3, Open-Label, Safety Extension Study of Oral Edaravone (Radicava ORS®) Administered Over 96 Weeks in Patients with ALS (MT-1186-A03)
General Neurology
S27 - General Neurology 2 (2:12 PM-2:24 PM)
007
Radicava® (edaravone) IV (intravenous; MTPA, hereafter “MTPA IV edaravone”) and MTPA oral edaravone were approved by the US Food and Drug Administration (FDA) for the treatment of ALS in 2017 and 2022, respectively, and studies have demonstrated these approved formulations have similar pharmacokinetics. Study MT-1186-A01 indicated that MTPA oral edaravone was well-tolerated over 48 weeks, with no new safety concerns identified. 
To evaluate the safety of Radicava ORS® (edaravone) oral suspension (Mitsubishi Tanabe Pharma America [MTPA], hereafter “MTPA oral edaravone”) in patients with amyotrophic lateral sclerosis (ALS) over 96 weeks.
Study MT-1186-A03 (NCT04577404) was a phase 3, open-label, multi-center, extension study that evaluated the long-term safety of MTPA oral edaravone over an additional 96 weeks in patients who have completed the initial 48 weeks of Study MT-1186-A01. Participants received MTPA oral edaravone (105-mg dose) according to the FDA-approved dosing for MTPA IV edaravone. Upon entering Study MT-1186-A01, patients had definite, probable, probable-laboratory-supported, or possible ALS; baseline forced vital capacity ≥70%; and baseline disease duration ≤3 years.
In Study MT-1186-A03, MTPA oral edaravone was well tolerated with no new safety concerns. The most common treatment-emergent adverse events (TEAEs) were fall, muscular weakness, dyspnea, constipation, and dysphagia. These TEAEs were consistent with the safety profile for MTPA edaravone from previous clinical trials.
MTPA oral edaravone showed no new safety concerns and was well-tolerated during the 96-week study period of MT-1186-A03, for a total of 144 weeks when including Study MT-1186-A01.
Authors/Disclosures
Alejandro Salah, MD, PhD, MBA, MHA
PRESENTER 		Dr. Salah has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma.
Angela L. Genge, MD (Mcgill University) Dr. Genge has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AL-S Pharma. Dr. Genge has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amylyx. Dr. Genge has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Quralis. Dr. Genge has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MTPA. Dr. Genge has received personal compensation in the range of $0-$499 for serving as a Consultant for WAVE. Dr. Genge has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for eikonizo. Dr. Genge has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for pepgen. Dr. Genge has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for rapa.
Gary L. Pattee, MD (Neurology Associates PC) The institution of Dr. Pattee has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MTPA pharmaceuticals. The institution of Dr. Pattee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MTPA pharmaceiticals. The institution of Dr. Pattee has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Catalyst. The institution of Dr. Pattee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for General Dynamics US military. The institution of Dr. Pattee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Otsuka pharmaceuticals.
Gen Sobue, MD (Nagoya University School Of Medicine/Dept. of Neurology) Dr. Sobue has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Mistubishi Tanabe Pharma Corporation. Dr. Sobue has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Nippon Chemiphar Co., Ltd.. Dr. Sobue has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Mistubishi Tanabe Pharma Corporation. Dr. Sobue has received personal compensation in the range of $0-$499 for serving as an Expert Witness for Takeda Pharmaceutical Company Limited..
Masashi Aoki, MD, PhD (Day Neuromuscular Research Laboratory) Masashi Aoki, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Tanabe Mitsubishi.
Hiide Yoshino, MD Dr. Yoshino has nothing to disclose.
Philippe Couratier, PhD Dr. Couratier has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Couratier has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Couratier has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier .
Christian Lunetta, MD Dr. Lunetta has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Lunetta has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen.
Susanne Petri, MD Prof. Petri has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amylyx. Prof. Petri has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ferrer. Prof. Petri has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zambon. Prof. Petri has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Prof. Petri has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Italfarmaco. Prof. Petri has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Zambon. Prof. Petri has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Prof. Petri has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amylyx. The institution of Prof. Petri has received research support from ALS Research Inc,. The institution of Prof. Petri has received research support from German Neuromuscular Scociety. The institution of Prof. Petri has received research support from Karlheinz Hartmann-Foundation. The institution of Prof. Petri has received research support from Petermax Müller-Foundation.
Daniel Selness (Mitsubishi Tanabe Pharma America, Inc) Mr. Selness has received personal compensation for serving as an employee of Mitsubishi Tanabe.
Vesna Todorovic, MD Dr. Todorovic has nothing to disclose.
Manabu Hirai Mr. Hirai has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma America.
Stephen Apple Stephen Apple has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma America, Inc.
Arthur Wamil, MD, PhD Dr. Wamil has received personal compensation for serving as an employee of Mitsubishi Tanabe.
Alexander Kalin Alexander Kalin has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma America, Inc..
Carlayne E. Jackson, MD, FAAN (University of Texas Health Science Center at San Antonio) Dr. Jackson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mitsubishi Tanabe Pharma America. Dr. Jackson has received personal compensation in the range of $100,000-$499,999 for serving as an officer or member of the Board of Directors for AAN. The institution of Dr. Jackson has received research support from NIH. The institution of Dr. Jackson has received research support from Massachussetts General Hospital.