A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT00444613 | Completed Phase 2

• 1 other identifier: E0302-J081-761
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 44

Brief Summary

The purpose of this study is to investigate the efficacy and confirm the safety of E0302 in patients with Amyotrophic Lateral Sclerosis (ALS) by assessing changes in scores of survival rate and functional rating scale.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Keywords

Amyotrophic Lateral Sclerosis (ALS); motor neurons; muscular atrophy; Lou Gehrig's Disease

Outcome Measures

Primary Outcomes (2)

• Survival rate

  Every 3 months.

• Functional rating scale.

  Every 3 months.

Secondary Outcomes (2)

• Manual Muscle Test (MMT)

  Every 3 months.

• Percent-predicted forced vital capacity (%FVC)

  Every 3 months.

Study Arms (3)

E0302 25 mg

EXPERIMENTAL

Drug: E0302 (mecobalamin)

E0302 50 mg

EXPERIMENTAL

Drug: E0302 (mecobalamin)

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

E0302 (mecobalamin) DRUG

Intramuscular injection, mecobalamin 25 mg twice a week for 3.5 years.

Also known as: mecobalamin

E0302 25 mg

Placebo DRUG

Intramuscular injection, placebo twice a week for 3.5 years.

3

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are able to submit written informed consent. If patients are duly capable of study consent but are unable to sign (or affix a seal) by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation.
• Patients who are aged 20 years or older at the time of obtaining informed consent.
• Patients who have clinically definite ALS, clinically probable ALS, or clinically probable-laboratory supported ALS as specified in the revised El Escorial Airlie House diagnostic criteria.
• Patients who are at stage 1 or 2 of the severity criteria for ALS.
• Patients within 3-year elapsed time period from disease onset at the start of observation period.
• Patients who can visit study site for out-patient treatment.

You may not qualify if:

• Patients who underwent tracheostomy.
• Patients who experienced non-invasive positive pressure ventilation.
• Patients whose percent-predicted forced vital capacity (%FVC) is \>=60%.
• Patients with multiple disturbances of conduction detected by nerve conduction test.
• Patients with neurological symptom(s) due to vitamin B12 deficiency.
• Patients who initiated newly introduced riluzole therapy after starting the observation period. Or those who received dose escalation or resumed administration of riluzole therapy after previous down titration or discontinuation.
• Patients with cognitive impairment.
• Pregnant women or women with a possibility of becoming pregnant.
• Patients or their partners who are not willing to use reliable contraception.
• Patients with severe disease in the renal, cardiovascular, hematological, or hepatic system (severe disease will be judged referring to "Ministry of Health, Labor and Welfare" (MHLW) Drug Safety Dept. Notification No. 80, Drug Safety Classification Criteria for Severity of Adverse Drug Reaction by Medicinal Products, Grade 3).
• Patients with malignant tumor.
• Patients who participated in another clinical study within 12 weeks before starting the observation period.
• Patients with present illness or history of drug allergy or severe allergic disease (anaphylactic shock).
• Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (44)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

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Akita, Akita, Japan

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Aomori, Aomori, Japan

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Chiba, Chiba, Japan

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Touon-shi, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyusyu-shi, Fukuoka, Japan

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Fukushima, Fukushima, Japan

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Maebashi, Gunma, Japan

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Higashihiroshima-shi, Hiroshima, Japan

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Miyoshi-shi, Hiroshima, Japan

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Otake-shi, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Kanazawa, Ishikawa-ken, Japan

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Ichinoseki-shi, Iwate, Japan

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Sagamihara-shi, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Nangoku-shi, Kochi, Japan

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Kyoto, Kyoto, Japan

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Tsu, Mie-ken, Japan

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Sendai, Miyagi, Japan

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Watari-gun, Miyagi, Japan

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Nagano, Nagano, Japan

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Higashisonogi-gun, Nagasaki, Japan

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Kashiwazaki-shi, Niigata, Japan

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Niigata, Niigata, Japan

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Tsukubo-gun, Okayama-ken, Japan

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Ginowan-shi, Okinawa, Japan

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Toyonaka-shi, Osaka, Japan

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Hasuda-shi, Saitama, Japan

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Saitama-shi, Saitama, Japan

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Ōtsu, Shiga, Japan

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Hamamatsu, Shizuoka, Japan

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Shizuoka, Shizuoka, Japan

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Shimotsuke-shi, Tochigi, Japan

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Tokushima, Tokushima, Japan

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Yoshinogawa-shi, Tokushima, Japan

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Bunkyo-ku, Tokyo, Japan

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Kodaira-shi, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Wakayama, Wakayama, Japan

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Yonezawa-shi, Yamagata, Japan

Location

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Shimonoseki-shi, Yamaguchi, Japan

Location

Unknown Facility

Yanai-shi, Yamaguchi, Japan

Location

Related Publications (2)

• Kaji R, Imai T, Iwasaki Y, Okamoto K, Nakagawa M, Ohashi Y, Takase T, Hanada T, Shimizu H, Tashiro K, Kuzuhara S. Ultra-high-dose methylcobalamin in amyotrophic lateral sclerosis: a long-term phase II/III randomised controlled study. J Neurol Neurosurg Psychiatry. 2019 Apr;90(4):451-457. doi: 10.1136/jnnp-2018-319294. Epub 2019 Jan 13.

  PMID: 30636701 DERIVED

• 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.

  PMID: 25982504 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Muscular Atrophy

Interventions

mecobalamin

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Kazunori Saeki

  Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2007
• First Posted: March 8, 2007
• Study Start: April 1, 2007
• Primary Completion: March 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 18, 2023

Record last verified: 2014-12

Locations

JP (44)