Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS
Phase 3
Terminated
NCT04569084
| Condition | ALS |
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| Phase | Phase 3 |
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| Sponsor | Shionogi |
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| Status | Terminated |
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| Enrollment | 384 participants |
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| Interventions | MT-1186 |
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| Start date | Nov 13, 2020 |
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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 change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline up to Week 48:
CAFS Score at Week 48
up to 48 Weeks · Units on a scale
| Edaravone 105 mg (Once Daily) | 187.2 Units on a scale |
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| Edaravone 105mg (2 Weeks On/Off ) | 184.2 Units on a scale |
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Open in BENITIONS
View on ClinicalTrials.gov
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