A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00444613 |
Recruitment Status :
Completed
First Posted : March 8, 2007
Last Update Posted : December 8, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis (ALS) | Drug: E0302 (mecobalamin) Drug: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 373 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase II/III Study in Patients With Amyotrophic Lateral Sclerosis (ALS) |
Study Start Date : | April 2007 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: E0302 25 mg |
Drug: E0302 (mecobalamin)
Intramuscular injection, mecobalamin 25 mg twice a week for 3.5 years.
Other Name: mecobalamin |
Experimental: E0302 50 mg |
Drug: E0302 (mecobalamin)
Intramuscular injection, mecobalamin 50 mg twice a week for 3.5 years.
Other Name: mecobalamin |
Placebo Comparator: 3 |
Drug: Placebo
Intramuscular injection, placebo twice a week for 3.5 years. |
- Survival rate [ Time Frame: Every 3 months. ]
- Functional rating scale. [ Time Frame: Every 3 months. ]
- Manual Muscle Test (MMT) [ Time Frame: Every 3 months. ]
- Percent-predicted forced vital capacity (%FVC) [ Time Frame: Every 3 months. ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444613
Japan | |
Nagoya-shi, Aichi, Japan | |
Akita-shi, Akita, Japan | |
Aomori-shi, Aomori, Japan | |
Chiba-shi, Chiba, Japan | |
Touon-shi, Ehime, Japan | |
Fukuoka-shi, Fukuoka, Japan | |
Kitakyusyu-shi, Fukuoka, Japan | |
Fukushima-shi, Fukushima, Japan | |
Maebashi-shi, Gunma, Japan | |
Higashihiroshima-shi, Hiroshima, Japan | |
Miyoshi-shi, Hiroshima, Japan | |
Otake-shi, Hiroshima, Japan | |
Sapporo-shi, Hokkaido, Japan | |
Kanazawa-shi, Ishikawa, Japan | |
Ichinoseki-shi, Iwate, Japan | |
Sagamihara-shi, Kanagawa, Japan | |
Yokohama-shi, Kanagawa, Japan | |
Nangoku-shi, Kochi, Japan | |
Kyoto-shi, Kyoto, Japan | |
Tsu-shi, Mie, Japan | |
Sendai-shi, Miyagi, Japan | |
Watari-gun, Miyagi, Japan | |
Nagano-shi, Nagano, Japan | |
Higashisonogi-gun, Nagasaki, Japan | |
Kashiwazaki-shi, Niigata, Japan | |
Niigata-shi, Niigata, Japan | |
Tsukubo-gun, Okayama, Japan | |
Ginowan-shi, Okinawa, Japan | |
Toyonaka-shi, Osaka, Japan | |
Hasuda-shi, Saitama, Japan | |
Saitama-shi, Saitama, Japan | |
Otsu-shi, Shiga, Japan | |
Hamamatsu-shi, Shizuoka, Japan | |
Shizuoka-shi, Shizuoka, Japan | |
Shimotsuke-shi, Tochigi, Japan | |
Tokushima-shi, Tokushima, Japan | |
Yoshinogawa-shi, Tokushima, Japan | |
Bunkyo-ku, Tokyo, Japan | |
Kodaira-shi, Tokyo, Japan | |
Ota-ku, Tokyo, Japan | |
Wakayama-shi, Wakayama, Japan | |
Yonezawa-shi, Yamagata, Japan | |
Shimonoseki-shi, Yamaguchi, Japan | |
Yanai-shi, Yamaguchi, Japan |
Study Director: | Kazunori Saeki | Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd. |
Responsible Party: | Eisai Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00444613 |
Other Study ID Numbers: |
E0302-J081-761 |
First Posted: | March 8, 2007 Key Record Dates |
Last Update Posted: | December 8, 2014 |
Last Verified: | December 2014 |
Amyotrophic Lateral Sclerosis (ALS) motor neurons muscular atrophy Lou Gehrig's Disease |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies |
Proteostasis Deficiencies Metabolic Diseases Vitamin B 12 Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |