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Effect, Safety and Pharmacokinetics Study of PRO051 to Treat DMD

Recruiting
Conditions
Duchenne Muscular Dystrophy
Registration Number
NL-OMON21367
Lead Sponsor
Prosensa
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
18
Inclusion Criteria

1. Boys aged between 5 and 16 years inclusive

2. Duchenne muscular dystrophy resulting from a mutation correctable by treatment with PRO051

Exclusion Criteria

1. Aberrant RNA splicing and/or aberrant response to PRO051, detected by in vitro PRO051 assay during screening

2. Known presence of dystrophin in > 5% of fibres in a pre-study diagnostic muscle biopsy

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Effect of PRO051 on dystrophin expression in muscle and on muscle strength and function <br /><br><br /><br>Safety and tolerability of PRO051<br /><br><br>Pharmacokinetics of PRO051
Secondary Outcome Measures
NameTimeMethod
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