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A Phase 3 Study of TAS-205 in Patients With Duchenne Muscular Dystrophy（REACH-DMD）

Duchenne Muscular Dystrophy Clinical Trial

Official title:
A Phase 3, Randomized, Placebo-controlled, Double-blind and Open-label, Extension Study of TAS-205 in Patients With Duchenne Muscular Dystrophy

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of TAS-205 in patients with Duchenne muscular dystrophy

Clinical Trial Description

[Ambulatory Cohort] The main purpose of this cohort is to assess the efficacy of TAS-205 in patients with Duchenne muscular dystrophy (DMD) compared with placebo as measured by the mean change from baseline to 52 weeks in the time to rise from the floor． Following completion of the treatment period, patients may elect to continue in open-label extension study. [Non-ambulatory Cohort] The main purpose of this cohort is to assess the safety of TAS-205 in patients with DMD by collecting the incidence of adverse events for 52 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04587908
Study type Interventional
Source Taiho Pharmaceutical Co., Ltd.
Contact Drug Information Center
Phone +81-3-3294-4527
Email toiawase@taiho.co.jp
Status Recruiting
Phase Phase 3
Start date November 1, 2020
Completion date May 2027
View Details
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