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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03548311
Other study ID # 763
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 1, 2017
Est. completion date March 31, 2020

Study information

Verified date June 2018
Source University of Tokushima
Contact Yuisin Izumi, MD
Phone 81-88-633-7207
Email yizumi@tokushima-u.ac.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 128
Est. completion date March 31, 2020
Est. primary completion date February 28, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Drug:
methylcobalamin
Patients receive methylcobalamin 50mg intramuscular injection twice a week.
saline solution
Patients receive saline solution intramuscular injection twice a week.

Locations

Country Name City State
Japan Chiba University Hospital Chiba
Japan Murakami Karindo Hospital Fukuoka
Japan Ioh National Hospital Kanazawa Ishikawa
Japan Kobe Central Munincipal Medical center Kobe Hyogo
Japan Miyoshi Neurological Clinic Miyoshi Hiroshima
Japan Nagoya University Hospital Nagoya Aichi
Japan Okayama University Hospital Okayama
Japan Shiga Medical University Hospital Otsu Shiga
Japan Kitasato University East Hospital Sagamihara Kanagawa
Japan Sapporo Medical University Hospital Sapporo Hokkaido
Japan Tokushima University Hospital Tokushima
Japan Juntendo University Hospital Tokyo
Japan Teikyo University Hospital Tokyo
Japan Toho University Hospital Tokyo
Japan Tokyo Metropolitan Neurological Hospital Tokyo
Japan Wakayama Medical University Hospital Wakayama

Sponsors (2)

Lead Sponsor Collaborator
University of Tokushima Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (2)

Ikeda K, Iwasaki Y, Kaji R. Neuroprotective effect of ultra-high dose methylcobalamin in wobbler mouse model of amyotrophic lateral sclerosis. J Neurol Sci. 2015 Jul 15;354(1-2):70-4. doi: 10.1016/j.jns.2015.04.052. Epub 2015 May 8. — View Citation

Kaji R, Kodama M, Imamura A, Hashida T, Kohara N, Ishizu M, Inui K, Kimura J. Effect of ultrahigh-dose methylcobalamin on compound muscle action potentials in amyotrophic lateral sclerosis: a double-blind controlled study. Muscle Nerve. 1998 Dec;21(12):17 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other safety any adverse events during the study period during 16 weks of test period
Primary ALSFRS-R Drop of Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (maximum or normal 48 and minimum 0; higher values represent better condition) during 16 weks of test period
Secondary survival time period from drug assignment to death or becoming bound to respirator during 16 weeks of test period
Secondary %Functional Vital Capacity (FVC) changes of per cent Functional Vital Capacity during 16 weeks of test period
Secondary homocystein changes of serum levels of homocystein during 16 weeks of test period
Secondary Manual Muscle Testing (MMT) changes of sum of Medical Research Council scales of manual muscle testing, ranging 5 (normal), 4, 4+, 3, 2, 1, 0 (minimal) ( for analysis each is converted to 6, 5, 4, 3, 2, 1, 0) of the 11 muscles in the limbs (5x2) and neck(1) during 16 weeks of test period
Secondary Norris scale changes of Norris scale (39 normal - 0 worst) during 16 weeks of test period
Secondary Grip Power changes of sum of grip power in kilograms on both sides during 16 weeks of test period
Secondary 40-item Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) changes of sum of ALSAQ-40 (40-item Amyotrophic Lateral Sclerosis Assessment Questionnaire) score (40 normal - 200 worst) during 16 weks of test period
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