A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Study Purpose:
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.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALSStudy Type:
Interventional TrialStudy Category:
Drug TrialStudy Status:
EnrollingPhase:
Phase IIIStudy Chair(s)/Principal Investigator(s):
Head of Medical Science, Mitsubishi Tanabe Pharma Development America, Inc.
Clinicaltrials.gov ID (11 digit #):
NCT04569084Neals Affiliated?
NoCoordinating Center Contact Information
Mitsubishi Tanabe Pharma Development America, Inc.Clinical Trials Information Desk / .(JavaScript must be enabled to view this email address)
.(JavaScript must be enabled to view this email address) United States