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Safety Study of Eteplirsen to Treat Early Stage Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy (DMD) Clinical Trial

Official title:
An Open-Label, Multi-Center Study to Evaluate the Safety, Efficacy and Tolerability of Eteplirsen in Early Stage Duchenne Muscular Dystrophy

Clinical Trial Summary

This is an open-label study to assess the safety, tolerability, efficacy and pharmacokinetics of eteplirsen in patients with early stage Duchenne muscular dystrophy (DMD) who are amenable to exon 51 skipping.

Clinical Trial Description

Safety, including adverse event monitoring and routine laboratory assessments, will be followed on an ongoing basis for all patients. Clinical efficacy, including functional tests and MRI, will be assessed at regularly scheduled study visits. Patients will undergo one baseline and one follow-up muscle biopsy. Population and serial PK will be collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02420379
Study type Interventional
Source Sarepta Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date June 30, 2015
Completion date December 17, 2018
View Details
See also
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