At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 124 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.
A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)
In Brief
A Phase 3 clinical trial evaluating MT-1186 for Amyotrophic Lateral Sclerosis (ALS). Completed, enrolled 124 participants across 44 sites in 6 countries.
Detailed Summary
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis (ALS)
CountriesCanada, France, Germany, Italy, Japan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedOct 2020
Enrollment StartOct 2020
Primary CompletionAug 2023
TodayJul 2026
First PostedOct 6, 2020
Enrollment StartOct 29, 2020
Primary CompletionAug 9, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 5.7 years ago
Interventions
MT-1186drug
Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country.