Informations about the clinical trial "Prednisone and Cyclosporin A in DMD" from Prof.Dr. Rudolf Korinthenberg:

Our study is a randomized placebo controlled trial that started in January 2004. There are 10 study centers in Germany, Swizzerland and probably Austria who will have to recruit 150 Boys over 5 years. During the first 3 months of treatment we compare Cyclosporin monotherapy to placebo. We want to see whether strength increases as was suggested by 2 open studies. During the following 12 months both groups (CsA and Placebo) will in addition be treated with prednisone in an intermittent scheme. Here we want to find out whether the effect of prednisone can be improved by CsA. Additionally, of course, we monitor side effects.

Previous studies with cyclosporin:

1993 - Neurology, Vol 43, Issue 3 527-532: Cyclosporine increases muscular force generation in Duchenne muscular dystrophy KR Sharma, MA Mynhier and RG Miller
We investigated the effect of cyclosporine (CsA) on force generation in 15 boys with Duchenne muscular dystrophy (DMD) by obtaining monthly measures of tetanic force and maximum voluntary contraction (MVC) of both anterior tibial muscles. During 4 months of a natural history phase, both tetanic force and MVC declined significantly. During 8 weeks of CsA treatment (5 mg/kg/day), significantly increased tetanic force (25.8 +/- 6.6%) and MVC (13.6 +/- 4.0%) occurred within 2 weeks. The maximum mean increase during treatment was 35.2 +/- 5.9% (tetanic force) and 19.0 +/- 4.6% (MVC). Side effects from CsA, gastrointestinal and flu-like symptoms, were transient and self-limiting. Thus, as previously reported with prednisone, CsA increases muscular force generation in the anterior tibial muscles of DMD patients. 

1997 - Muscle Nerve, 20, 469–478. Myoblast implantation in Duchenne Muscular Dystrophy: The San Francisco Study

ABSTRACT: We evaluated myoblast implantation in 10 boys with Duchenne muscular dystrophy (DMD) and absent dystrophin (age 5–10 years) who were implanted with 100 million myoblasts in the anterior tibial muscle of one leg and placebo in the other. Cyclosporine (5 mg/kg/day) was administered for 7 months. Pre- and postimplantation (after 1 and 6 months) muscle biopsies were analyzed. Force generation (tetanic tension and maximum voluntary contraction) was measured monthly in a double-blind design. There was increased force generation in both legs of all boys, probably due to cyclosporine. Using the polymerase chain reaction, evidence of myoblast survival and dystrophin mRNA expression was obtained in 3 patients after 1 month and in 1 patient after 6 months. These studies suggest a salutary effect of cyclosporine upon muscular force generation in Duchenne muscular dystrophy; however, myoblast implantation was not effective in replacing clinically significant amounts of dystrophin inDMD muscle.