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.

Conditions: Male and female patients with Parkinson´s disease meeting UKPDS criteria
MedDRA version: 12.1Level: LLTClassification code 10013113Term: Disease Parkinson's

Registration Number: EUCTR2009-017416-33-DE

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•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;

Exclusion Criteria

•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.