Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS
Phase 3
Terminated
NCT05151471
| Condition | ALS |
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| Phase | Phase 3 |
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| Sponsor | Tanabe Pharma America, Inc. |
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| Status | Terminated |
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| Enrollment | 202 participants |
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| Interventions | MT-1186 |
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| Start date | Jan 11, 2022 |
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| Completion date | Sep 29, 2023 |
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| Results posted | Mar 27, 2025 |
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Summary
To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that country
Time From the Randomization Date in Study MT-1186-A02 to at Least a 12-point Decrease in ALSFRS-R or Death, Whichever Happens First.
Up to 96 weeks · Month
| Edaravone 105 mg (Once Daily) | 13.9 Month |
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| Edaravone 105 mg (on/Off) | 15.05 Month |
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Open in BENITIONS
View on ClinicalTrials.gov
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