Open Label Study of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

• Status: Terminated
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to explore long-term safety, tolerability and efficacy of GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion Criteria:

• Previous participation in either DMD114117 or DMD114044

• Continued use of glucocorticoids

• Willing and able to comply with all protocol requirements

• Able to give informed consent

• French subjects: Eligible for inclusion only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

• Subject experienced a serious adverse event or who met safety stopping criteria that remains unresolved from DMD114117 or DMD114044, which in opinion of the investigator could have been attributable to study medication and is ongoing,

• Use of anticoagulants, antithrombotics or antiplatelet agents, previous treatment with investigational drugs,except GSK2402968, within 1 month of the first administration of study medication,

• Current or anticipated participation in any investigational clinical studies,

• History of significant medical disorder which may confound the interpretation of either efficacy or safety data e.g. current history of renal or liver disease/impairment, history of inflammatory disease.