Overview

Clinical Trial of Ultra-high Dose Methylcobalamin for ALS

Status:
Unknown status
Trial end date:
2020-03-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Tokushima
Collaborator:
Eisai Co., Ltd.
Treatments:
Pharmaceutical Solutions
Vitamin B 12
Criteria
Inclusion Criteria:

- ALS patients within 12 months after clinical onset at the entry

- Updated Awaji combined with El Escorial criteria: definite, probably or laboratory
supported probable

- Decline of ALSFRSR being 1 or 2 during observation period of 12 weeks

- Japanese Clinical Severity Scale 1 or 2

- Those who can visit the participating medical centers

Exclusion Criteria:

- Those who have tracheostomy

- Those who had NIPPV

- %FVC<60%

- Those who have Chronic Obstructive Pulmonary Disease (COPD)

- Those who have symptoms and signs of B12 deficiency

- Those who had edaravone less than 4 weeks prior to entry

- Those who changed the schedule and dosing of riluzole

- Those who have dementia

- Those who have the possibility of pregnancy

- Those who have serious respiratory or cardiac diseases

- Those who have malignancies

- Those who participated other clinical trials within 12 weeks

- Those who have allergies to B12 and related compounds