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Clinical Trial of Ultra-high Dose Methylcobalamin for ALS

NCT03548311 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-03-26

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

methylcobalamin

Patients receive methylcobalamin 50mg intramuscular injection twice a week.

DRUG

saline solution

Patients receive saline solution intramuscular injection twice a week.

Sponsors & Collaborators

  • University of Tokushima

    collaborator OTHER

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ryuji Kaji, MD · Tokushima University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2020-02-14
Completion
2025-02-18

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03548311 on ClinicalTrials.gov