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

NCT04587908 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-09-11

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Taiho Pharmaceutical Co., Ltd. · Taiho Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04587908 on ClinicalTrials.gov