A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Effect of EDG-5506 on Biomarker Response to Exercise in Adults with Becker Muscular Dystrophy, McArdle Disease, or Limb-Girdle Muscular Dystrophy
Secondary identifiers
interventional
N/A
1 country
1
To assess the safety of sevasemten in adults with neuromuscular disease. To assess the effect of sevasemten treatment on biomarkers of muscle damage in adults with Becker Muscular Dystrophy (BMD), McArdle disease, or Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 4, 2022
Actual (reported)Incidence, frequency, and severity of adverse events and serious adverse events in those treated with EDG-5506 or placebo.
Change in serum creatine kinase (CK) from baseline to week 16.
Change in serum CK from pre-exercise baseline to week 52.
Incidence of treatment-emergent abnormal laboratory test results (clinical chemistry, hematology, and urinalysis). Change from Baseline in: - Safety laboratory parameters - Vital signs - Physical and neurological examination - Electrocardiogram (ECG) parameters - Cardiac function as assessed by echocardiogram - Pulmonary function as assessed by spirometry (FEV1,FVC) - C-SSRS (Columbia Suicide Severity Rating Scale)
Steady state plasma concentrations of sevasemten
Rigshospitalet
Copenhagen Oe, 2100, Denmark
Edgewise Clinical Studies
First Submitted
August 4, 2022
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
A Study to Assess Safety, Tolerability, and PK of EDG-5506 in Healthy Volunteers and Becker Muscular Dystrophy Adults
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