A Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects with Treated Parkinson's Disease (PD). Longterm Study - 1 (LS-1)
The primary study aim of this trial is to compare the effect of creatine with placebo on progression of Parkinson's disease over 5 years. The primary outcome will compare the mean rank sum of five measures in the creatine group versus the placebo group against a background of dopaminergic therapy and best medical care.
The research hypothesis is that the group being treated with creatine will show less disease progression by 5 years than the group on placebo as evaluated by a Global Statistical Test.