| First Published on Clinicaltrials.gov: |
3/6/2007 |
| Status: |
Ongoing, But Not Recruiting |
| ClinicalTrials.gov ID: |
NCT00444613 |
| Sponsor: |
Eisai Limited |
| 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. |
| Phase: |
II/III |
| Treatment Type: |
Injection |
| Trial Type: |
Double Blind, Placebo Control |
| Estimated Enrollment: |
360 |
| Eligibility: |
20 years and older. Both Genders. No healthy volunteers |
| Details: |
Three arm study: experimental injection of E0302 25mg twice per week for 3.5 years, experimental injection of E0302 50mg twice per week for 3.5 years, placebo comparator injection twice per week for 3.5 years. |
| Collaborator(s): |
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| Location(s): |
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| Primary Investigator: |
Kazunori Saeki Department New Drug Development, Clinical Research Center |
| Contact: |
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| Trial Protocol as Published on Clinicaltrials.gov: |
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| ALS Forum: |
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