Interventional {{label}}

Clinical Trial of Ultra-high Dose Methylcobalamin for ALS

Please note: All trial information reflects the latest data available from the sponsor on ClinicalTrials.gov and other public databases. However, these sources may occasionally be outdated or inaccurate. For the most current information, we recommend contacting the trial sponsor or sites directly.

Overview

Intervention or Drug Name

Sponsor

Trial Status

Phase

Randomization

Trial Duration

Route of Administration

Genetic Target

Repurposed Drugs

Approved by FDA

Approved outside USA

Is a supplement

Details

Enrollment Criteria

Time since symptom onset

Vital Capacity (FVC or SVC)

Approved Medications

Registry Listing

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Purpose

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.

What participation looks like

Eligibility criteria

20 Years and older, all genders, not accepting healthy volunteers

Locations

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