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Abstract Details

Perampanel for Sporadic Amyotrophic Lateral Sclerosis
General Neurology
P6 - Poster Session 6 (12:00 PM-1:00 PM)
6-011

There are limited treatments for amyotrophic lateral sclerosis (ALS). Perampanel, selective non-competitive α-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) receptor antagonist, has been reported to rescue motor dysfunction and neuropathology in sporadic ALS model mice, in which is an RNA editing enzyme adenosine deaminase acting on RNA 2 is conditionally knocked out in motor neurons, suggesting therapeutic potency of perampanel for sporadic ALS.

To investigate the safety and the efficacy of perampanel in patients with sporadic amyotrophic lateral sclerosis.

We conducted a multicenter randomized, double-blinded, placebo-controlled, parallel-group phase 2 clinical trial to evaluate the efficacy and safely of perampanel at doses of 4mg and 8mg per day, as compared with placebo, in patients with sporadic ALS. Sporadic ALS patients, aged 40 years to 78 years who have clinically definite ALS, clinically probable ALS, or clinically probable-laboratory supported ALS as a specified in the revised El Escorial Airline House diagnostic criteria, were registered. The primary outcome measure is the change in ALS functional rating scale-revised (ALSFRS-R) scores after 48 weeks of the treatment. Secondary outcomes include change in ALSFRS-R slope, manual muscle test, and percent-predicted forced vital capacity. Mixed effect model repeated measures analysis was used for statistics.

Of 79 patients eligible for interim registration, 66 patients underwent randomization to assign to 3 groups: 8mg of perampanel, 4mg of perampanel, and placebo. This study will be completed in January 2020. The results this study will be available in February 2010. (Funded by Japan Agency for Medical Research and Development, AMED; CrinicalTrials.gov number, NCT03019419.)

The conclusions will be updated at the 72nd annual meeting of American Academy of Neurology.

Authors/Disclosures
Hitoshi Aizawa
PRESENTER
No disclosure on file
Haruhisa Kato No disclosure on file
Koji Oba No disclosure on file
Takuya Kawahara No disclosure on file
Yoshihiko Okubo No disclosure on file
Tomoko Saito No disclosure on file
Makoto Urushitani No disclosure on file
Akira Tamaoka No disclosure on file
Kiyotaka Nakamagoe No disclosure on file
Kazuhiro Ishii No disclosure on file
Takashi Kanda, MD (Dept. of Neurology, Medical and Dental University) No disclosure on file
Masahisa Katsuno No disclosure on file
Naoki Atsuta No disclosure on file
Yasushi Maeda No disclosure on file
Makiko Nagai, MD (Tohoku USM/Dept of Neuro) No disclosure on file
Kazutoshi Nishiyama, MD, PhD Kazutoshi Nishiyama, MD, PhD has nothing to disclose.
Hiroyuki Ishiura, MD (The University of Tokyo) No disclosure on file
Tatsushi Toda No disclosure on file
Akihiro Kawata No disclosure on file
Koji Abe No disclosure on file
Ichiro Yabe, MD, PhD (Hokkaido University) No disclosure on file
Ikuko Takahashi (Faculty of Medicine and Graduate School of Medicine, Hokkaido University) No disclosure on file
Hidenao Sasaki No disclosure on file
Hitoshi Warita No disclosure on file
Masashi Aoki, MD,PhD (Day Neuromuscular Research Laboratory) No disclosure on file
Gen Sobue, MD (Nagoya University School Of Medicine/Dept. of Neurology) Dr. Sobue has nothing to disclose.
Hidehiro Mizusawa, MD, PhD (National Center of Neurology and Psychiatry) No disclosure on file
Yutaka Matsuyama No disclosure on file
Shin Kwak No disclosure on file