NCT04587908

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Taiho Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
DRUG	TAS-205 [Ambulatory Cohort] [Non-ambulatory Cohort]	・Treatment period：oral administration for 52 weeks, BID after meal
DRUG	Placebo [Ambulatory Cohort] only	* Observation period：oral administration for 2 weeks, BID after meal * Treatment period：oral administration for 52 weeks, BID after meal

Timeline

• Start date: 2020-11-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2020-10-14
• Last updated: 2025-09-11

Locations

5 sites across 1 country: Japan