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Sponsored by: |
Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00445172 |
The purpose of this study is to investigate the safety and efficacy of long-term E0302 administration in patients with Amyotrophic Lateral Sclerosis (ALS).
Condition | Intervention | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis (ALS) |
Drug: E0302 (mecobalamin) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Long-Term Study in Patients With Amyotrophic Lateral Sclerosis (ALS) |
Estimated Enrollment: | 300 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: E0302 (mecobalamin)
Intramuscular injection, mecobalamin 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 Service Department. CRC and QA | _ML_CLNCL@hhc.eisai.co.jp |
Study Director: | Kazunori Saeki | Department New Drug Development Clinical Research Center |
Responsible Party: | Eisai Compnay Ltd. ( Kazunori Saeki, Study Director ) |
Study ID Numbers: | E0302-J081-762 |
Study First Received: | March 6, 2007 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00445172 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Amyotrophic Lateral Sclerosis Motor Neurons Muscular Atrophy |
Lou Gehrig's Disease Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Central Nervous System Diseases Atrophy |
Sclerosis Neurodegenerative Diseases Degenerative Motor System Disease Motor Neuron Disease Muscular Atrophy |
Pathologic Processes Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Nervous System Diseases |
Central Nervous System Diseases Sclerosis Neurodegenerative Diseases Motor Neuron Disease |