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Clinical Trial of Ultra-high Dose Methylcobalamin for ALS — JETALS  

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
Japanese Early-stage Clinical Trial of Ultra-high Dose Methylcobalamin for Amyotrophic Lateral Sclerosis: a Pivotal Phase 3 Randomized Controlled Study

Clinical Trial Summary

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 Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03548311
Study type Interventional
Source University of Tokushima
Contact Yuisin Izumi, MD
Phone 81-88-633-7207
Email yizumi@tokushima-u.ac.jp
Status Recruiting
Phase Phase 3
Start date November 1, 2017
Completion date March 31, 2020
View Details
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