Clinical Trial of Ultra-high Dose Methylcobalamin for ALS

Eisai Co., Ltd.130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

130

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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. Exclusion Criteria: Treatment and OLE Phase: * 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 Tsunagi Phase: Not applicable.

Locations (16)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Miyoshi Neurological Clinic

Miyoshi, Hiroshima, Japan

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Kobe Central Munincipal Medical center

Kobe, Hyōgo, Japan

Ioh National Hospital

Kanazawa, Ishikawa-ken, Japan

Kitasato University East Hospital

Sagamihara, Kanagawa, Japan

Shiga Medical University Hospital

Ōtsu, Shiga, Japan

Chiba University Hospital

Chiba, Japan

Murakami Karindo Hospital

Fukuoka, Japan

Okayama University Hospital

Okayama, Japan

...and 6 more locations

Outcomes

Primary Outcomes

Treatment Phase: ALSFRS-R

Drop of Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (maximum or normal 48 and minimum 0; higher values represent better condition)