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A Phase IIa Study of TAS-205 for Duchenne Muscular Dystrophy

NCT02752048 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-04-20

Study results available
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Summary

The objective of this study is to evaluate the efficacy after 24-week repeated oral doses of TAS-205 in patients with Duchenne Muscular Dystrophy (DMD) in an exploratory manner.

Conditions

Interventions

DRUG

TAS-205

2 groups: Low dose group, High dose group. Oral administration for 24 weeks, bis in die (BID) after meal

DRUG

Placebo

1 group: Placebo group. Oral administration for 24 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
2016-05-31
Primary Completion
2017-05-15
Completion
2017-10-17

Countries

  • Japan

Study Locations

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Entities

Drugs
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 NCT02752048 on ClinicalTrials.gov