EDG-5506-203 MESA is an open-label extension study to assess the long-term effect of sevasemten (EDG-5506) on safety, biomarkers, and functional measures in adults and adolescents with Becker muscular dystrophy
This is an open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of sevasemten. EDG-5506-203 MESA will provide continued access to sevasemten treatment to participants with Becker muscular dystrophy who were previously enrolled in EDG-5506-002 ARCH, completed EDG-5506-201 CANYON and GRAND CANYON, or completed EDG-5506-202 DUNE.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Sevasemten is administered orally once per day
Number of adverse events in those treated with sevasemten
Time frame: 55 Months
Severity of adverse events in those treated with sevasemten
Time frame: 55 Months
Incidence of treatment-emergent abnormal clinical chemistry laboratory test results
Time frame: 54 Months
Incidence of treatment-emergent abnormal hematology laboratory test results
Time frame: 54 Months
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