A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS)
1 other identifier
interventional
135
1 country
42
Brief Summary
The purpose of this study is to investigate the safety and efficacy of long-term E0302 administration in patients with Amyotrophic Lateral Sclerosis (ALS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2008
Longer than P75 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2007
CompletedFirst Posted
Study publicly available on registry
March 8, 2007
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedJune 18, 2023
August 1, 2017
9.2 years
March 6, 2007
June 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with Adverse Events as a Measure of safety
Every 3 months
Secondary Outcomes (3)
Survival rate
Every 3 months
Functional rating scale
Every 3 months
Percent-predicted forced vital capacity (%FVC.)
Every 3 months
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- Patients with cognitive impairment.
- Pregnant women or women who may have 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." However, an event due to the primary disease will be precluded).
- Patients with malignant tumor.
- Patients who participated in another clinical study after the completion of Study 761.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (42)
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Aomori, Aomori, Japan
Unknown Facility
Chiba, Chiba, Japan
Unknown Facility
Touon-shi, Ehime, Japan
Unknown Facility
Fukuoka, Fukuoka, Japan
Unknown Facility
Kitakyushi-shi, Fukuoka, Japan
Unknown Facility
Fukushima, Fukushima, Japan
Unknown Facility
Maebashi, Gunma, Japan
Unknown Facility
Higashihiroshima-shi, Hiroshima, Japan
Unknown Facility
Miyoshi-shi, Hiroshima, Japan
Unknown Facility
Otake-shi, Hiroshima, Japan
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Kanazawa, Ishikawa-ken, Japan
Unknown Facility
Ichinoseki-shi, Iwate, Japan
Unknown Facility
Sagamihara-shi, Kanagawa, Japan
Unknown Facility
Yokohama, Kanagawa, Japan
Unknown Facility
Nangoku-shi, Kochi, Japan
Unknown Facility
Kyoto, Kyoto, Japan
Unknown Facility
Tsu, Mie-ken, Japan
Unknown Facility
Sendai, Miyagi, Japan
Unknown Facility
Watari-gun, Miyagi, Japan
Unknown Facility
Nagano, Nagano, Japan
Unknown Facility
Higashisonogi-gun, Nagasaki, Japan
Unknown Facility
Kashiwazaki-shi, Niigata, Japan
Unknown Facility
Niigata, Niigata, Japan
Unknown Facility
Tsukubo-gun, Okayama-ken, Japan
Unknown Facility
Ginowan-shi, Okinawa, Japan
Unknown Facility
Toyonaka-shi, Osaka, Japan
Unknown Facility
Hasuda-shi, Saitama, Japan
Unknown Facility
Saitama-shi, Saitama, Japan
Unknown Facility
Hamamatsu, Shizuoka, Japan
Unknown Facility
Shizuoka, Shizuoka, Japan
Unknown Facility
Shimotsuke-shi, Tochigi, Japan
Unknown Facility
Tokushima, Tokushima, Japan
Unknown Facility
Yoshinogawa-shi, Tokushima, Japan
Unknown Facility
Bunkyo-ku, Tokyo, Japan
Unknown Facility
Kodaira-shi, Tokyo, Japan
Unknown Facility
Ōta-ku, Tokyo, Japan
Unknown Facility
Wakayama, Wakayama, Japan
Unknown Facility
Yonezawa-shi, Yamagata, Japan
Unknown Facility
Shimonoseki-shi, Yamaguchi, Japan
Unknown Facility
Yanai-shi, Yamaguchi, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kazunori Saeki
Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2007
First Posted
March 8, 2007
Study Start
February 1, 2008
Primary Completion
March 31, 2017
Study Completion
March 31, 2017
Last Updated
June 18, 2023
Record last verified: 2017-08