Study 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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
methylcobalamin, saline solution
Placebo:
Yes
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
Ryuji Kaji, MD, Tokushima University Hospital
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Yuisin Izumi, MD / email hidden; JavaScript is required / 81-88-633-7207
Study Sponsor:
University of Tokushima
Estimated Enrollment:
128
Estimated Study Start Date:
11 / 01 / 2017
Estimated Study Completion Date:
03 / 31 / 2020
Posting Last Modified Date:
06 / 26 / 2018
Date Study Added to neals.org:
06 / 07 / 2018
Minimum Age:
20 Years
Maximum Age:
N/A
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
Nagoya University Hospital | Recruiting
Naoki Atsuta, MD / 81-52-741-2111
Nagoya, Aichi
466-8560
Japan
Miyoshi Neurological Clinic | Recruiting
Masaya Oda, MD
Miyoshi, Hiroshima
728-0013
Japan
Sapporo Medical University Hospital | Recruiting
Shun Shimohama, MD / 81-11-611-2111
Sapporo, Hokkaido
060-8543
Japan
Kobe Central Munincipal Medical center | Recruiting
Nobuo Kohara, MD / 81-78-302-4321
Kobe, Hyogo
650-0047
Japan
Ioh National Hospital | Recruiting
Kiyonobu Komai, MD / 81-76-258-1180
Kanazawa, Ishikawa
920-0192
Japan
Kitasato University East Hospital | Recruiting
Makiko Nagai, MD / 81-42-748-9111
Sagamihara, Kanagawa
252-0380
Japan
Shiga Medical University Hospital | Recruiting
Makoto Urushidani, MD / 81-77-548-2111
Otsu, Shiga
520-2192
Japan
Chiba University Hospital | Recruiting
Satoshi Kuwabara, MD / 81-43-222-7171 / email hidden; JavaScript is required
Chiba 260-8677
Japan
Murakami Karindo Hospital | Recruiting
Hitoshi Kikuchi, MD / 81-92-811-3331
Fukuoka 819-8585
Japan
Okayama University Hospital | Recruiting
Koji Abe, MD / 88-86-223-7151 / email hidden; JavaScript is required
Okayama 770-8558
Japan
Tokushima University Hospital | Recruiting
Hiroyuki Nodera, MD / 81-88-633-9658 / email hidden; JavaScript is required
Tokushima 770-8503
Japan
Juntendo University Hospital | Recruiting
Kazuaki Kanai, MD
Tokyo 113-8431
Japan
Toho University Hospital | Recruiting
Tokyo 143-8541
Japan
Teikyo University Hospital | Recruiting
Masahiro Sonoo, MD
Tokyo 173-8606
Japan
Tokyo Metropolitan Neurological Hospital | Recruiting
Tokyo 183-0042
Japan
Wakayama Medical University Hospital | Recruiting
Hidefumi Ito, MD / 81-73-447-2300
Wakayama 641-8509
Japan