A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)
NCT ID: NCT00445172
Last Updated: 2023-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
135 participants
INTERVENTIONAL
2008-02-29
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
E0302 (mecobalamin)
Intramuscular injection, mecobalamin twice a week.
Interventions
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E0302 (mecobalamin)
Intramuscular injection, mecobalamin twice a week.
Eligibility Criteria
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Inclusion Criteria
2. 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.
Exclusion Criteria
2. Pregnant women or women who may have a possibility of becoming pregnant.
3. Patients or their partners who are not willing to use reliable contraception.
4. 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." However, an event due to the primary disease will be precluded).
5. Patients with malignant tumor.
6. Patients who participated in another clinical study after the completion of Study 761.
7. Patients with present illness or history of drug allergy or severe allergic disease (anaphylactic shock).
8. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.
20 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Kazunori Saeki
Role: STUDY_DIRECTOR
Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Locations
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Nagoya, Aichi-ken, Japan
Aomori, Aomori, Japan
Chiba, Chiba, Japan
Touon-shi, Ehime, Japan
Fukuoka, Fukuoka, Japan
Kitakyushi-shi, Fukuoka, Japan
Fukushima, Fukushima, Japan
Maebashi, Gunma, Japan
Higashihiroshima-shi, Hiroshima, Japan
Miyoshi-shi, Hiroshima, Japan
Otake-shi, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Kanazawa, Ishikawa-ken, Japan
Ichinoseki-shi, Iwate, Japan
Sagamihara-shi, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Nangoku-shi, Kochi, Japan
Kyoto, Kyoto, Japan
Tsu, Mie-ken, Japan
Sendai, Miyagi, Japan
Watari-gun, Miyagi, Japan
Nagano, Nagano, Japan
Higashisonogi-gun, Nagasaki, Japan
Kashiwazaki-shi, Niigata, Japan
Niigata, Niigata, Japan
Tsukubo-gun, Okayama-ken, Japan
Ginowan-shi, Okinawa, Japan
Toyonaka-shi, Osaka, Japan
Hasuda-shi, Saitama, Japan
Saitama-shi, Saitama, Japan
Hamamatsu, Shizuoka, Japan
Shizuoka, Shizuoka, Japan
Shimotsuke-shi, Tochigi, Japan
Tokushima, Tokushima, Japan
Yoshinogawa-shi, Tokushima, Japan
Bunkyo-ku, Tokyo, Japan
Kodaira-shi, Tokyo, Japan
Ōta-ku, Tokyo, Japan
Wakayama, Wakayama, Japan
Yonezawa-shi, Yamagata, Japan
Shimonoseki-shi, Yamaguchi, Japan
Yanai-shi, Yamaguchi, Japan
Countries
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Other Identifiers
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E0302-J081-762
Identifier Type: -
Identifier Source: org_study_id
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