Status:
COMPLETED
A Study of TAS-205 for Duchenne Muscular Dystrophy
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
5-15 years
Phase:
PHASE1
Brief Summary
The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in patients with Duchenne Muscular Dystrophy.
Detailed Description
Duchenne Muscular Dystrophy (DMD) is the most common fatal genetic disorder diagnosed in childhood, affecting approximately 1 in every 3500 lives male births. DMD patients suffer from a relentless dec...
Eligibility Criteria
Inclusion
- Able to give an informed consent. If applicable, able to give an informed assent.
- Male and \>= 5 years and \< 16 years of age.
- Bodyweight of \>= 15.0 kg and \< 75.0 kg.
- Phenotypic evidence of DMD.
- Able to take tablets.
- If taking oral glucocorticosteroids no significant change in total daily dosage or dosing regimen after enrollment.
- Confirmed the urinary PD marker over its criteria.
- Able to follow the study protocol.
Exclusion
- Current diagnosis or history of any drug allergy.
- A forced vital capacity (FVC) \< 50% of predicted value.
- A left ventricular ejection fraction (EF) \< 50% or fractional shortening (FS) \< 25% based on echocardiogram (ECHO).
- Ongoing immunosuppressive therapy (other than corticosteroids).
- With severe disease such as hepatic disease, kidney disease and others.
- With any systemic allergic disease or any chronic inflammatory disease.
- Treated with any other investigational agents within 90 days.
- Positive reaction in hepatitis B surface antigen (HbsAg), hepatitis C antibody test (HCV), or human immunodeficiency virus (HIV) test.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT02246478
Start Date
September 1 2014
End Date
September 1 2015
Last Update
June 4 2021
Active Locations (1)
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1
National Center of Neurology and Psychiatry
Tokyo, Japan, 187-8551