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The purpose of this study is to evaluate the efficacy and safety of TAS-205 in patients with Duchenne muscular dystrophy
Full 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.
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Inclusion and exclusion criteria
Key Inclusion Criteria [Ambulatory Cohort]
[Non-ambulatory Cohort]
Key exclusion Criteria [Ambulatory Cohort]
[Non-ambulatory Cohort]
Primary purpose
Allocation
Interventional model
Masking
104 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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