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A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)

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. Identifier: NCT00444613
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : December 8, 2014
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Drug: E0302 (mecobalamin) Drug: Placebo Phase 2 Phase 3

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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.

Primary Outcome Measures :
  1. Survival rate [ Time Frame: Every 3 months. ]
  2. Functional rating scale. [ Time Frame: Every 3 months. ]

Secondary Outcome Measures :
  1. Manual Muscle Test (MMT) [ Time Frame: Every 3 months. ]
  2. Percent-predicted forced vital capacity (%FVC) [ Time Frame: Every 3 months. ]

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Patients who are aged 20 years or older at the time of obtaining informed consent.
  3. 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.
  4. Patients who are at stage 1 or 2 of the severity criteria for ALS.
  5. Patients within 3-year elapsed time period from disease onset at the start of observation period.
  6. Patients who can visit study site for out-patient treatment.

Exclusion Criteria:

  1. Patients who underwent tracheostomy.
  2. Patients who experienced non-invasive positive pressure ventilation.
  3. Patients whose percent-predicted forced vital capacity (%FVC) is >=60%.
  4. Patients with multiple disturbances of conduction detected by nerve conduction test.
  5. Patients with neurological symptom(s) due to vitamin B12 deficiency.
  6. 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.
  7. Patients with cognitive impairment.
  8. Pregnant women or women with a possibility of becoming pregnant.
  9. Patients or their partners who are not willing to use reliable contraception.
  10. 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).
  11. Patients with malignant tumor.
  12. Patients who participated in another clinical study within 12 weeks before starting the observation period.
  13. Patients with present illness or history of drug allergy or severe allergic disease (anaphylactic shock).
  14. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00444613

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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
Sponsors and Collaborators
Eisai Co., Ltd.
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Study Director: Kazunori Saeki Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Eisai Co., Ltd. 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
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Amyotrophic Lateral Sclerosis (ALS)
motor neurons
muscular atrophy
Lou Gehrig's Disease
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral 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
Physiological Effects of Drugs