Clinical Trial of Ultra-high Dose Methylcobalamin for ALS
Status:
Unknown status
Trial end date:
2020-03-31
Target enrollment:
Participant gender:
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.