This trial has completed recruitment on this platform, and is no longer accepting new referrals.
A study to assess the safety, tolerability and preliminary efficacy of ASP0367(MA-0211) in pediatric male participants with Duchenne muscular dystrophy (DMD)
Trial ID: NCT04184882
We are testing ASP0367, an investigational drug, to find out if it relieves key Duchenne Muscular Dystrophy (DMD) symptoms. ASP0367 is designed to increase the number and function of the mitochondria in cells, thereby increasing energy production. This has the potential to improve muscle health and function, reduce inflammation, and increase endurance in people living with DMD.
A Phase 1b clinical trial is open now in the United States. The primary purpose of the study is to test the safety and side effects of ASP0367, and to learn how the body processes it. The study is also looking at how ASP0367 affects muscle function (e.g. using an arm cycling test). This study has four parts and takes up to 8 months to finish in total.
If you choose not to take part in the optional open-label period, the study will take 5 months to finish.
What’s Involved
The study takes up to 8 months to finish in total. If participants do not choose to take part in the open-label part, the study takes about 5 months to complete. Participants will take the tablet by mouth each day during the treatment period.
Participants will complete tests related to their health and condition at about seven hospital visits and eight home visits by a qualified home healthcare provider, as well as through follow-up phone calls. These tests may include a physical examination (height, weight, vital signs), 12-lead electrocardiogram (ECG), heart imaging (echocardiography), blood/urine test, assisted 6-minute arm cycling test, examination of arms, 2-minute walk test, breathing function tests, and participant questionnaires.
Travel support is available for clinical trial participants and their families.
Additional site locations will become available on a rolling basis. Please check back if you do not see an enrolling site near you.
You will need to bring your child to one of the study clinics taking part in this clinical trial.
Sites are located in the cities/states identified with the red pin: