Back to resultsCRD007 for the Treatment of Duchenne Muscular Dystrophy, Becker Muscular Dystrophy and Symptomatic Carriers
Primary Purpose
Duchenne Muscular Dystrophy, Becker Muscular Dystrophy
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
CRD007
Sponsored by
About this trial
This is an interventional trial for Duchenne Muscular Dystrophy focused on measuring DMD, BMD, symptomatic carriers
Eligibility Criteria
Inclusion Criteria:
- Documented diagnosis of dystrophinopathy
Exclusion Criteria:
- Severe functional impairment
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CRD007 10 mg tablet
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01540604
Brief Title
CRD007 for the Treatment of Duchenne Muscular Dystrophy, Becker Muscular Dystrophy and Symptomatic Carriers
Official Title
An Open-label, Un-controlled, Single-centre Trial Investigating the Efficacy and Safety of CRD007 in Children With Duchenne Muscular Dystrophy (DMD) or Becker Muscular Dystrophy (BMD) or Children Being Symptomatic Carriers for DMD or BMD
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RSPR Pharma AB
4. Oversight
5. Study Description
Brief Summary
This is an investigation of the efficacy and safety of CRD007 in Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy (BMD) and symptomatic carriers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy, Becker Muscular Dystrophy
Keywords
DMD, BMD, symptomatic carriers
7. Study Design
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Arm Title
CRD007 10 mg tablet
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CRD007
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Eligibility Criteria
Inclusion Criteria:
Documented diagnosis of dystrophinopathy
Exclusion Criteria:
Severe functional impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T Sejersen, MD PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
CRD007 for the Treatment of Duchenne Muscular Dystrophy, Becker Muscular Dystrophy and Symptomatic Carriers
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