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:

6/8/2018Trial 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 clinial efficacy and safety of ultra-high dose (50mg, im, twice a week) methylcobalamin in retarding the progression of symptoms in amyotrophic lateral sclerosis (ALS) patinets, 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 ALSFRSR 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 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