Clinical Trial of Ultra-high Dose Methylcobalamin for ALS

Clinical Trial of Ultra-high Dose Methylcobalamin for ALS

Quick Info:

Status:
Currently Recruiting
Estimated Enrollment:
128
Phase:
3
Treatment Type:
Drug: methylcobalamin
Trial Type:
Randomized, Parallel Assignment, Double-blind
Sponsor:
University of Tokushima
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
<60% FVC
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
≤ 12 months
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
no
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
no
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Unknown

Update Notes:

6/27/2018No significant updates
6/8/2018Trial added

Locations:

Chiba University Hospital , Chiba
Ioh National Hospital , Ishikawa
Juntendo University Hospital , Tokyo
Kitasato University East Hospital , Kanagawa
Kobe Central Munincipal Medical center , Hyogo
Miyoshi Neurological Clinic , Hiroshima
Murakami Karindo Hospital , Fukuoka
Nagoya University Hospital Nagoya, Nagoya, 466-8560
Okayama University Hospital , Okayama
Sapporo Medical University Hospital , Hokkaido
Shiga Medical University Hospital , Shiga
Teikyo University Hospital , Tokyo
Toho University Hospital , Tokyo
Tokushima University Hospital , Tokushima
Tokyo Metropolitan Neurological Hospital , Tokyo
Wakayama Medical University Hospital , Wakayama

Other Information:

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.
Eligibility: 20 Years and older, all genders, not accepting healthy volunteers
Details:
Collaborator(s):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 6/7/2018
ClinicalTrials.gov ID: NCT03548311
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov