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Sponsored by: |
Eisai Limited |
Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00444613 |
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 | Intervention | Phase |
Amyotrophic Lateral Sclerosis (ALS) |
Drug: E0302 Drug: Placebo |
Phase II Phase III |
Genetics Home Reference related topics: | amyotrophic lateral sclerosis |
MedlinePlus related topics: | Amyotrophic Lateral Sclerosis |
Drug Information available for: | Mecobalamin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II/III Study in Patients With Amyotrophic Lateral Sclerosis (ALS) |
Estimated Enrollment: | 300 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: E0302
Drug: E0302 (Muscle Injection, twice a week)
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2: Experimental |
Drug: E0302
Drug: E0302 (Muscle Injection, twice a week)
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3: Placebo Comparator |
Drug: Placebo
Drug: Placebo (Muscle Injection, twice a week)
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Customer Information Services Department.CRC and QA | ML_CLNCL@hhc.eisai.co.jp |
Japan, Gunma | |||||
Recruiting | |||||
Maebashi-shi, Gunma, Japan | |||||
Japan, Miyagi | |||||
Recruiting | |||||
Watari-gun, Miyagi, Japan | |||||
Japan, Okayama | |||||
Recruiting | |||||
Tsukubo-gun, Okayama, Japan | |||||
Japan, Saitama | |||||
Recruiting | |||||
Saitama-shi, Saitama, Japan | |||||
Japan, Tokyo | |||||
Recruiting | |||||
Kodaira-shi, Tokyo, Japan |
Eisai Limited |
Study Director: | Kazunori Saeki | Department New Drug Development, Clinical Research Center |
Responsible Party: | Eisai Company Limited ( Department of New Product Development, Clinical Research Center ) |
Study ID Numbers: | E0302-J081-761 |
First Received: | March 6, 2007 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00444613 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency; Japan: Ministry of Health, Labor and Welfare |
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