NCT03548311CompletedPhase 3
Clinical Trial of Ultra-high Dose Methylcobalamin for ALS
Japanese Early-stage Clinical Trial of Ultra-high Dose Methylcobalamin for Amyotrophic Lateral Sclerosis: a Pivotal Phase 3 Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 26 Mar 2025
Brief summary (registry, in English)
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 Updated Awaji 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 130 (actual)
- First submitted
- 14 May 2018
- Start date
- 1 Nov 2017
- Primary completion date
- 14 Feb 2020
- Lead sponsor
- Eisai Co., Ltd.
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT03548311
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 130
- From 1 Nov 2017 to the primary completion date, 14 Feb 2020
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who had edaravone less than 4 weeks prior to entry
Other illness
- Those who have Chronic Obstructive Pulmonary Disease (COPD)
- Those who have dementia
- Those who have serious respiratory or cardiac diseases
- Those who have malignancies
- Those who have allergies to B12 and related compounds
- Tsunagi Phase:
- Not applicable.
Other
- Treatment and OLE Phase:
- Those who have tracheostomy
- Those who had NIPPV
- %FVC\<60%
- Those who have symptoms and signs of B12 deficiency
- Those who changed the schedule and dosing of riluzole
- Those who have the possibility of pregnancy
- Those who participated other clinical trials within 12 weeks
Who the study is looking for
- Treatment and OLE Phase:
- ALS patients within 12 months after clinical onset at the entry
- Diagnosed based on updated Awaji 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
- Tsunagi Phase:
- \- The subjects for the Tsunagi phase are patients with ALS who are continuing the administration of this drug at the time of approval, and have obtained consent for the transition to the Tsunagi phase.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chiba University Hospital Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Murakami Karindo Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Ioh National Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Kobe Central Munincipal Medical center Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Miyoshi Neurological Clinic Coordinator of this site? Confirm its status | Miyoshi | Japan | Unknown status |
| Nagoya University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Shiga Medical University Hospital Coordinator of this site? Confirm its status | Ōtsu | Japan | Unknown status |
| Kitasato University East Hospital Coordinator of this site? Confirm its status | Sagamihara | Japan | Unknown status |
| Sapporo Medical University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Tokushima University Hospital Coordinator of this site? Confirm its status | Tokushima | Japan | Unknown status |
| Tokyo Metropolitan Neurological Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Teikyo University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Toho University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Wakayama Medical University Hospital Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
Related publications
- Efficacy and Safety of Ultrahigh-Dose Methylcobalamin in Early-Stage Amyotrophic Lateral Sclerosis: A Randomized Clinical Trial.JAMA Neurol · 2022 · PMID 35532908
- The Japanese Early-Stage Trial of High-Dose Methylcobalamin for Amyotrophic Lateral Sclerosis (JETALS): Protocol for a Randomized Controlled Trial.JMIR Res Protoc · 2018 · PMID 30578206
This page is information, not medical advice. Discuss any trial with your doctor.