At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 185 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.
Safety Study of Oral Edaravone Administered in Subjects With ALS
In Brief
A Phase 3 clinical trial evaluating MT-1186 for ALS. Completed, enrolled 185 participants across 53 sites in 6 countries.
Detailed Summary
The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsALS
CountriesCanada, France, Germany, Italy, Japan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 2019
Enrollment StartNov 2019
Primary CompletionOct 2021
TodayJul 2026
First PostedNov 18, 2019
Enrollment StartNov 18, 2019
Primary CompletionOct 7, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.6 years ago
Interventions
MT-1186drug
* An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug free period * Subsequent treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period. Treatment cycles are every 4 weeks.