Clinical Trial of Ultra-high Dose Methylcobalamin for ALS

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03548311
• Date of registration: 14/05/2018
• Prospective Registration: No
• Primary sponsor: University of Tokushima
• Public title: Clinical Trial of Ultra-high Dose Methylcobalamin for ALS JETALS
• Scientific title: Japanese Early-stage Clinical Trial of Ultra-high Dose Methylcobalamin for Amyotrophic Lateral Sclerosis: a Pivotal Phase 3 Randomized Controlled Study
• Date of first enrolment: November 1, 2017
• Target sample size: 128
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03548311
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Yuisin Izumi, MD

• Name: Ryuji Kaji, MD
• Affiliation: Tokushima University Hospital

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: saline solution

Drug: methylcobalamin

Primary Outcome(s)

ALSFRS-R [Time Frame: during 16 weks of test period]

Secondary Outcome(s)

%Functional Vital Capacity (FVC) [Time Frame: during 16 weeks of test period]

Manual Muscle Testing (MMT) [Time Frame: during 16 weeks of test period]

Norris scale [Time Frame: during 16 weeks of test period]

Grip Power [Time Frame: during 16 weeks of test period]

homocystein [Time Frame: during 16 weeks of test period]

survival [Time Frame: during 16 weeks of test period]

40-item Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) [Time Frame: during 16 weks of test period]

Secondary ID(s)

763

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eisai Co., Ltd.