Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial.
- Conditions
- Parkinson's diseaseMedDRA version: 12.1Level: LLTClassification code 10013113Term: Disease Parkinson's
- Registration Number
- EUCTR2010-022363-35-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
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method