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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. |
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Register:
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EUCTR |
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Last refreshed on:
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3 April 2017 |
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Main ID: |
EUCTR2005-000663-26-AT |
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Date of registration:
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21/03/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Immunsuppressive Therapy in Duchenne Muscular Dystrophy - DMD-CsA
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Scientific title:
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Immunsuppressive Therapy in Duchenne Muscular Dystrophy - DMD-CsA |
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Date of first enrolment:
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25/04/2005 |
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Target sample size:
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150 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000663-26 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
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Countries of recruitment
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Austria
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Duchenne Muscular Dystrophy
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Intervention(s)
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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
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Primary Outcome(s)
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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)
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Secondary Objective:
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Primary end point(s): Manual Muscle testing on 32 muscle groups according to the modified Medical Research Council Scales (MRC)
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Secondary ID(s)
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MD-NET R17
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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