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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 3 April 2017
Main ID:  EUCTR2005-000663-26-AT
Date of registration: 21/03/2005
Prospective Registration: Yes
Primary sponsor: Universitätsklinik Freiburg
Public title: Immunsuppressive Therapy in Duchenne Muscular Dystrophy - DMD-CsA
Scientific title: Immunsuppressive Therapy in Duchenne Muscular Dystrophy - DMD-CsA
Date of first enrolment: 25/04/2005
Target sample size: 150
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000663-26
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV):
Countries of recruitment
Austria
Contacts
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Key inclusion & exclusion criteria
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


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes
Health Condition(s) or Problem(s) studied
Duchenne Muscular Dystrophy
Intervention(s)

Trade Name: Sandimmun Optoral

Product Name: Sandimmun Optoral
Product Code: 29180.00.00, 34681.00.00, 34681.01.00, 34681.02.00
Pharmaceutical Form: Capsule*
Other descriptive name: Cyclosporin A
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 3,5-4-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Decortin
Product Name: Decortin
Product Code: not available
Pharmaceutical Form: Tablet
Other descriptive name: Prednison
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 0,75 -10 d on/ 10 d off

Primary Outcome(s)
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)
Primary end point(s): Manual Muscle testing on 32 muscle groups according to the modified Medical Research Council Scales (MRC)
Secondary Objective:
Secondary Outcome(s)
Secondary ID(s)
MD-NET R17
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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