ALSに対する超高用量メチルコバラミンの臨床試験

基本情報

NCT ID

NCT03548311

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

130

治験依頼者名

Eisai Inc.

概要

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 Updated Awaji 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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (16)