Immunsuppressive Therapy in Duchenne Muscular Dystrophy - DMD-CsA
Phase 1
- Conditions
- Duchenne Muscular Dystrophy
- Registration Number
- EUCTR2005-000663-26-AT
- Lead Sponsor
- niversitätsklinik Freiburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 150
Inclusion Criteria
boys with certain diagnosis of Duchenne Muscular Dystrophy
minimum age of five years
preserved ability to walk
capability to cooperate
informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
previous treatment with steroids
changes of any medication within the last three months
containdications against Cyclosporin A or Prednison
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Investigation of effectivness and wholesomness of Cyclosporin A (= Sandimmun Optoral) in the treatment of Duchenne Muscular Dystrophy alone and in combination with Prednison (= Decortin);Secondary Objective: ;Primary end point(s): Manual Muscle testing on 32 muscle groups according to the modified Medical Research Council Scales (MRC)
- Secondary Outcome Measures
Name Time Method