Quick Search

 

 


 

 

Home > Protocol Summaries: Compounds > GSK2402968 > Protocol Summary for 114349

Protocol Summary for 114349

Protocol Summary
Protocol Id: 114349
Secondary Ids:
Title: An open-label extension study of the long-term safety, tolerability and efficacy of GSK2402968 in subjects with Duchenne Muscular Dystrophy
Phase: phase 3
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Belgium: Local Medical Ethics Committee
Collaborators:
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.
Detailed Description:
Record Verification Date: May 2013
Status: Recruiting
Why Study Stopped:
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Study Completion Date Type: Anticipated
Estimated Primary Completion Date: December 2014
Primary Completion Date Type: Anticipated
Primary Purpose: treatment
Allocation: Non-randomized
Masking: Open Label
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Single Group Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Differences between the 6MWD at baseline and Week 104 104 weeks
Secondary Outcomes:
  • Muscle strength 104 weeks
  • Health Utilities Index 104 weeks
  • Pulmonary Function 104 weeks
  • Frequency of accidental falls during 6 Minute Walk Distance test 104 weeks
  • Pediatric Quality of Life Neuromuscular module 104weeks
  • North Star Ambulatory Assessment Scores 104 weeks
  • Timed Function tests 104 weeks
  • Functional Outcomes Assessment 104 weeks
  • Clinician Global Impression of Improvement 104 weeks
  • Time to major disease milestones 104 weeks
  • Creatine kinase Serum concentrations 104 weeks
Conditions:
  • Muscular Dystrophies
Keywords:
  • 968
  • Duchenne
  • DMD
  • drisapersen
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Male
Minimum Age: 5 Year
Maximum Age:
Enrollment: 220
Enrollment Type: Anticipated
Healthy Volunteers?: none
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GlaxoSmithKline
Location and Contact Information: Click to view location information