|CI||Professor Volker Straub|
|sites||Newcastle and London GOSH|
A Phase III, multicentre, open-label extension, study in male outpatients with DMD. Patient will have to have participated in one of the previous GSK studies of the same drug.
All patients will receive 6mg/kg of the drug weekly or an intermittent dosing frequency. Patients will receive the drug for at least two years.
To assess the long term safety, tolerability and efficacy of subcutaneous 6mg/kg/week of the drug in DMD patients.
- the long-term pharmacokinetics (PK) of the drug
- the long-term impact on health-related quality of life (HRQoL) and functional outcomes of continued treatment with GSK2402968
- DMD disease progression and outcomes (clinical, HRQoL and functional) in subjects who stop active treatment during the study
- the long-term safety, efficacy and PK of an intermittent dose of the drug in patients unable to tolerate weekly doses
Approximately 200 subjects.