Clinical Trial of Ultra-high Dose Methylcobalamin for ALS (JETALS)

NCT03548311 PHASE3 COMPLETED

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.

Details

Lead sponsor	Eisai Co., Ltd.
Phase	PHASE3
Status	COMPLETED
Enrolment	130
Start date	Wed Nov 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Feb 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

• methylcobalamin
• saline solution

Countries

Japan