Parkinson's disease MedDRA version: 12.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's
Conditions
Interventions
Trade Name: Madopar LT
Product Name: Levodopa / Benserazid
Product Code: LD / BE
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: LEVODOPA
CAS Number: 59-92-7
Current Sponsor code: LD
Othe
Sponsors
Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - signed informed consent according to GCP-V and local law - male or female patients with Parkinson's disease according to Parkinson's Disease Society Brain Bank's criteria - age between 30 and 75 years - negative beta-HCG-test at the screening (exceptions: postmenopausal condition or surigacal sterilisation), women of child-bearing age have to use a secure contraceptive 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of the trial is the creation of "metabolic profiles" of two important pillars of therapy of Morbus Parkinson, namely Levodopa (+ Benserazide) and Rotigotin. The main focus is on the investigation of stress parameters and nerval growth factors, which are suspected of provoking neural lesions or may counteract such impairments. The following parameters should be investigated: - Cortisol (stress parameter and cardiovascular risk factor) - Dihydroepiandrosterone (potential antagonist of cortisol, neuroprotective effect) - cysteine-glycine (parameter for the quantification of oxidative stress) - nerval growth factor (diminished in case of PD) - 3-O-methyl-dopa and homocysteine as dopamine-metabolites;Secondary Objective: A possible correlation between cortisol concentration and the Cys-Gly concentration should be investigated. Furthermore, we want to get information in order to emphasise or to reject the hypothesis (compare Protocol version 1.0, point 1) concerning the levodopa-associated decrease of the cortisol concentration, since the dopamine agonist rotigotine as well as placebo aren't substrates of the dopa-decarboxylase. The correlation between the different medication and the motor symptoms (UPDRS III, tapping, peg insertion, vigorimeter) should be investigated in a standardisised way.;Primary end point(s): The primary end point is the standardisised evaluation of differences in the plasma levels of levodopa, its metabolite 3-OMD, homocysteine, and Cys-Gly and the serum levels of cortisol, NGF and DHEA according to the application of levodopa / benserazide, rotigotin and placebo and possible correlation to motor function, strength and subjective ability. | — |
Countries
Germany
Outcome results
None listed