Male and female patients with Parkinson´s disease meeting UKPDS criteria MedDRA version: 12.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's
Conditions
Interventions
Trade Name: Tasmar
Product Name: Tolcapon
Product Code: TO
Pharmaceutical Form: Coated tablet
INN or Proposed INN: TOLCAPONE
CAS Number: 134308-13-7
Current Sponsor code: TO
Concentration unit: mg mil
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 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 ;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
Exclusion criteria
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. ;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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of the trial is to test the individual response to levodopa and to determine the influence of Entacapon and Tolcpaon on the pharmacokinetics of Levodopa, on plasma level of homocystein and serum level of cortisol in a short applied period. All these parameters are compared to motor function, muscle strength and subkective ability. ;Secondary Objective: A secondary objective of the trial is to evaluate a possible diagnostic use of a short-time application of Levodopa/Carbidopa + COMT-Inhibitor as an "optimized Levodopa-Challenge". ;Primary end point(s): The primary endpoint of the trial is the standardized evaluation of differences in the plasma levels of levodopa, its metabolite 3-OMD, homocystein and the serum level of cortisol according to the application of levodopa/carbidopa, levodopa/carbidopa + entacapone and levodopa/carbidopa + tolcapone and possible correlation to motor function, strength and subjective ability. ;Main Objective: Main objective of the trial is to test the individual response to levodopa and to determine the influence of Entacapon and Tolcpaon on the pharmacokinetics of Levodopa, on plasma level of homocystein and serum level of cortisol in a short applied period. All these parameters are compared to motor function, muscle strength and subkective ability. ;Secondary Objective: A secondary objective of the trial is to evaluate a possible diagnostic use of a short-time application of Levodopa/Carbidopa + COMT-Inhibitor as an "optimized Levodopa-Challenge". ;Primary end point(s): The primary endpoint of the trial is the standardized evaluation of differences in the plasma levels of levodopa, its metabolite 3-OMD, homocystein and the serum level of cortisol according to the application of levodopa/carbidopa, levodopa/carbidopa + entacapone and levodopa/carbidopa + tolcapone and possible correlation to motor function, strength and subjective ability. | — |
Countries
Germany
Contacts
Public Contact; ;
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Outcome results
None listed