Study Purpose:
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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS)
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
E0302 (mecobalamin), Placebo
Placebo:
Phase:
Phase 2/Phase 3
Study Chair(s)/Principal Investigator(s):
Kazunori Saeki, Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Japan
Full Study Summary:
Study Sponsor:
Eisai Co., Ltd.
Estimated Enrollment:
373
Estimated Study Start Date:
03 / 31 / 2007
Estimated Study Completion Date:
07 / 01 / 2014
Posting Last Modified Date:
12 / 08 / 2014
Date Study Added to neals.org:
03 / 08 / 2007
Minimum Age:
20 Years
Maximum Age:
N/A
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.
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