UMC St Radboud in Nijmegen will start in November 2010 with the DeManDII study. It is a dose comparing study for exon 51 skipping in Duchenne Muscular Dystrophy patients.
A double blind placebo controlled comparison is made between:
1) a continuous weekly injection and
2) intermittent schedule of 10 weeks: 1 injection in week 1,3,5, and 2 injections in week 2,4,6, followed by 4 weeks no injection
3) placebo injection
The study will start in ten centres worldwide including: 2 centres in UK, 2 in Spain, 2 in Australia, 1 in France, 1 in Belgium, 1 in Germany, 1 in Turkey, and 1 in the Netherlands.
The whole study period will take 48 weeks, results are expected in 2012.