Drisapersen Duchenne Muscular Dystrophy (DMD) Treatment Protocol
|ClinicalTrials.gov Identifier: NCT01890798|
Recruitment Status : Withdrawn (Rights for the further development of drisapersen have been transferred to Prosensa. Therefore this study has been cancelled before enrollment.)
First Posted : July 2, 2013
Last Update Posted : March 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Muscular Dystrophies||Drug: Drisapersen||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Continued Access Protocol for Eligible US Subjects With Duchenne Muscular Dystrophy Who Previously Participated in an Approved Drisapersen Study|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||July 2015|
Experimental: Drisapersen (DMD117402)
The protocol is open only to the subjects who completed GSK protocol DMD114876 and participated in protocol DMD115501, United States citizens who have completed protocol DMD114044, or United States citizens who are participating in protocol DMD114349 outside the United States and want to end their participation in the DMD114349 study. Eligible subjects will receive drisapersen 6 milligram (mg)/kilograms (kg) once a week via subcutaneous (SC) injection.
Drisapersen will be supplied as 3 millilitre (mL) vials containing 1mL sterile solution for subcutaneous injection. The strength of drisapersen solution will be 200 mg/mL.
- Safety as assessed by the collection of adverse events (AEs) [ Time Frame: Baseline to Week 48 ]AEs will be collected from the start of Study Treatment and until 5 days post last-dose (at follow up).
- Safety as assessed by laboratory parameters [ Time Frame: Baseline to Week 48 ]Absolute values and changes over time of hematology, clinical chemistry, and urinalysis
- Safety as assesses by electrocardiogram (ECG) intervals [ Time Frame: Baseline to Week 48 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890798
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|