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An Extension Study of Ataluren (PTC124) in Participants With Nonsense Mutation Dystrophinopathy

Nervous System Diseases Clinical Trial

Official title:
A Phase 3 Extension Study of Ataluren (PTC124) in Patients With Nonsense Mutation Dystrophinopathy

Clinical Trial Summary

The primary objective of this study is to obtain long term safety data of ataluren in male participants with nonsense mutation dystrophinopathy (who participated and completed a previous Phase 3 study of ataluren [PTC124-GD-020-DMD {NCT01826487}]) to augment the overall safety database. Screening and baseline procedures are structured to avoid a gap in treatment between the double-blind study (PTC124-GD-020-DMD) and this extension study.

This study may be further extended by amendment until either ataluren becomes commercially available or the clinical development of ataluren in duchenne muscular dystrophy (DMD) is discontinued.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02090959
Study type Interventional
Source PTC Therapeutics
Contact
Status Terminated
Phase Phase 3
Start date March 20, 2014
Completion date June 12, 2018
View Details
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