Study Purpose:
The purpose of this study is to investigate the safety and efficacy of long-term E0302 administration in patients with Amyotrophic Lateral Sclerosis (ALS).Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS)
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
E0302 (mecobalamin)
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
United States
Full Study Summary:
Primary Outcome Measures:
-Number of participants with Adverse Events as a Measure of safety [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
-Survival rate [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
-Functional rating scale [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
-Percent-predicted forced vital capacity (%FVC.) [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
Study Sponsor:
Eisai Co., Ltd.
Estimated Enrollment:
135
Estimated Study Start Date:
02 / 01 / 2008
Estimated Study Completion Date:
03 / 31 / 2017
Posting Last Modified Date:
08 / 23 / 2017
Date Study Added to neals.org:
03 / 08 / 2007
Minimum Age:
20 Years
Maximum Age:
N/A
Inclusion Criteria:1. Patients who have completed Phase II/III study of E0302 (E0302-J081-761, hereafter referred to as Study 761) except for those patients who discontinued the treatment of Study 761. Completed patients are defined as those who completed the treatment period of Study 761, those on 24-hour use of non-invasive positive pressure ventilation (NIPPV), or those who eventually resulted in the use of NIPPV.
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:
1. Patients with cognitive impairment.
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.
Nagoya-shi, Aichi
Japan
Aomori-shi, Aomori
Japan
Chiba-shi, Chiba
Japan
Touon-shi, Ehime
Japan
Fukuoka-shi, Fukuoka
Japan
Kitakyushi-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
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