Status:
TERMINATED
Open Label Study of GSK2402968 in Subjects With Duchenne Muscular Dystrophy
Lead Sponsor:
GlaxoSmithKline
Conditions:
Muscular Dystrophies
Eligibility:
MALE
5+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT01480245
Start Date
September 1 2011
End Date
March 1 2014
Last Update
March 23 2017
Active Locations (59)
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1
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1125ABD
2
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
3
GSK Investigational Site
Parkville, Victoria, Australia, 3052
4
GSK Investigational Site
Ghent, Belgium, 9000