Immunsuppressive Therapy in Duchenne Muscular Dystrophy - DMD-CsA

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000663-26-AT

Enrollment

150

Registered

2005-03-21

Start date

2005-04-25

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne Muscular Dystrophy

Interventions

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 Con

Eligibility

Sex/Gender

Male

Inclusion 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

Exclusion criteria: previous treatment with steroids changes of any medication within the last three months containdications against Cyclosporin A or Prednison

Design outcomes

Primary

Measure	Time frame
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)	—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026