Merck KgaA has announced the completion of two Phase III clinical trials of Sarizotan in advanced Parkinson's disease patients suffering from dyskinesia.
The two placebo-controlled double-blind Phase III studies (PADDY-1 and PADDY-2) were performed in 15 countries worldwide in over 1,000 Parkinson patients with disabling dyskinesia. The treatment duration was six months with the first endpoint reached after three months. Sarizotan 1-mg tablets or a matching placebo were administered twice daily. The primary target variable of efficacy was based on the Unified Parkinson's Disease Rating Scale and included measures of severity as well as duration of patients' dyskinesia. Treatment response was defined as a 25 percent improvement or greater in the primary endpoint.