Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease

Summary

The purpose of this trial is to assess whether rotigotine has an effect on the electrical activity of the heart. Moxifloxacin infusion is used as positive control to assess assay sensitivity.

Timeline

Start

2006-01

Primary completion

2006-09

Completion

2006-10

Publications

• Results Malik M, Andreas JO, Hnatkova K, Hoeckendorff J, Cawello W, Middle M, Horstmann R, Braun M. Thorough QT/QTc study in patients with advanced Parkinson's disease: cardiac safety of rotigotine. Clin Pharmacol Ther. 2008 Nov;84(5):595-603. doi: 10.1038/clpt.2008.143. Epub 2008 Jul 23.
• Results Elshoff JP, Braun M, Andreas JO, Middle M, Cawello W. Steady-state plasma concentration profile of transdermal rotigotine: an integrated analysis of three, open-label, randomized, phase I multiple dose studies. Clin Ther. 2012 Apr;34(4):966-78. doi: 10.1016/j.clinthera.2012.02.008. Epub 2012 Mar 7.

Drugs

Indications