EUCTR2009-017416-33-DE
Active, not recruiting
Not Applicable
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 sitesDecember 21, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Male and female patients with Parkinson´s disease meeting UKPDS criteria
- Sponsor
- Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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;
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;
Outcomes
Primary Outcomes
Not specified
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