Drisapersen Duchenne Muscular Dystrophy (DMD) Treatment Protocol

Status Withdrawn

Clinical Trial Summary

This is a single arm, open-label continued access protocol of drisapersen for the treatment of male subjects with Duchenne muscular dystrophy (DMD) having dystrophin mutations correctable by drisapersen-induced DMD Exon 51 skipping. The purpose of this continued access protocol is to offer pre-approval access to drisapersen for the treatment of subjects with DMD who previously participated in eligible drisapersen studies. The protocol will collect safety data required to assure subject safety and periodic efficacy data on muscle function.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01890798
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Withdrawn
Phase	Phase 3
Start date	January 2014
Completion date	July 2015

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See also
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