Last updated on June 2018

Clinical Trial of Ultra-high Dose Methylcobalamin for ALS


Brief description of study

To examine the clinical efficacy and safety of ultra-high dose (50mg, im, twice a week) methylcobalamin in retarding the progression of symptoms in amyotrophic lateral sclerosis (ALS) patients, we enroll ALS patients diagnosed by revised-Awaji-El Escorial criteria within 12 months after the clinical onset. First they are followed for 12 weeks with Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised(ALSFRS-R) scores, and only those who exhibit drops of 1-2 points are allowed to enter into the test period. A total of 128 patients are randomized and the half having placebo. They are blindly evaluated for drops of ALSFRS-R in 16 weeks, as the primary outcome. After this, all subjects receive methylcobalamin.

Clinical Study Identifier: NCT03548311

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Naoki Atsuta, MD

Nagoya University Hospital
Nagoya, Japan
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Masaya Oda, MD

Miyoshi Neurological Clinic
Miyoshi, Japan
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Shun Shimohama, MD

Sapporo Medical University Hospital
Sapporo, Japan
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Nobuo Kohara, MD

Kobe Central Munincipal Medical center
Kobe, Japan
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Kiyonobu Komai, MD

Ioh National Hospital
Kanazawa, Japan
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Makiko Nagai, MD

Kitasato University East Hospital
Sagamihara, Japan
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Makoto Urushidani, MD

Shiga Medical University Hospital
Otsu, Japan
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Satoshi Kuwabara, MD

Chiba University Hospital
Chiba, Japan
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Hitoshi Kikuchi, MD

Murakami Karindo Hospital
Fukuoka, Japan
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Koji Abe, MD

Okayama University Hospital
Okayama, Japan
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Hiroyuki Nodera, MD

Tokushima University Hospital
Tokushima, Japan
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Kazuaki Kanai, MD

Juntendo University Hospital
Tokyo, Japan
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Yuisin Izumi, MD

Toho University Hospital
Tokyo, Japan
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Masahiro Sonoo, MD

Teikyo University Hospital
Tokyo, Japan
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Yuisin Izumi, MD

Tokyo Metropolitan Neurological Hospital
Tokyo, Japan
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Hidefumi Ito, MD

Wakayama Medical University Hospital
Wakayama, Japan
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