At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 15 enrolled
Drug / intervention
MT-1186drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Open-label Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With Amyotrophic Lateral Sclerosis (ALS)
In Brief
A Phase 3 clinical trial evaluating MT-1186 for ALS. Completed, enrolled 15 participants across 11 sites.
Detailed Summary
The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. This study will be continued until the earlier date when oral edaravone is commercially available at each site in Japan or August 2023.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsALS
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedOct 2022
Enrollment StartOct 2022
Primary CompletionJun 2023
TodayJul 2026
First PostedOct 5, 2022
Enrollment StartOct 26, 2022
Primary CompletionJun 27, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.7 years ago
Interventions
MT-1186drug
Suspension