Trials / Completed
CompletedNCT00444613
A Study in Patients With Amyotrophic Lateral Sclerosis (ALS)
A Phase II/III Study in Patients With Amyotrophic Lateral Sclerosis (ALS)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 373 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E0302 (mecobalamin) | Intramuscular injection, mecobalamin 25 mg twice a week for 3.5 years. |
| DRUG | E0302 (mecobalamin) | Intramuscular injection, mecobalamin 50 mg twice a week for 3.5 years. |
| DRUG | Placebo | Intramuscular injection, placebo twice a week for 3.5 years. |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2014-03-01
- Completion
- 2014-07-01
- First posted
- 2007-03-08
- Last updated
- 2023-06-18
Locations
44 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00444613. Inclusion in this directory is not an endorsement.