Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol.

Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University0 个研究点开始时间: 2009年12月21日最近更新: 2013年6月24日

适应症

试验速览

暂无简介。

•signed informed consent according to GCP-V and local law;
•male or female patients with Parkinson´s disease with at least 3 of the following symptoms: Resting tremor, Bradykinesia, Rigor and Asymmetria;
•Age between 30 and 75 years;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range
•signed informed consent according to GCP-V and local law;
•male or female patients with Parkinson´s disease with at least 3 of the following symptoms: Resting tremor, Bradykinesia, Rigor and Asymmetria;
•Age between 30 and 75 years;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Allergic reaction to Entacapon or Tolcapon or their ingredients in the medical history;
•Atypic parkinson Syndromes (drug induced, metabolic or by inflammation);
•clinically significant changes in routine lab testing and/or other internal or psychiatric diseases not according to parkinson´s disease;
•clinically signifikant changes in the general examination not according to parkinson´s disease;
•Diseases with changes in absorption, distribution or metabolism;
•deep brain stimulation in the medical history;
•pregnancy, planned pregnancy or nursing period, unwillingness to perform adequate contraception.
•Allergic reaction to Entacapon or Tolcapon or their ingredients in the medical history;
•Atypic parkinson Syndromes (drug induced, metabolic or by inflammation);
•clinically significant changes in routine lab testing and/or other internal or psychiatric diseases not according to parkinson´s disease;
•clinically signifikant changes in the general examination not according to parkinson´s disease;
•Diseases with changes in absorption, distribution or metabolism;
•deep brain stimulation in the medical history;
•pregnancy, planned pregnancy or nursing period, unwillingness to perform adequate contraception.

发起方

Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University