A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE
- Conditions
- Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.
- Registration Number
- EUCTR2005-002654-21-NO
- Lead Sponsor
- Solvay Pharmaceuticals GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
Patients on permanent treatment with Duodopa for at least 12 weeks prior to the study.
or
Duodopa treatment naïve patients. In this case the following must be fulfilled:
The Investigator considers changing conventional PD treatment. The criteria in the Summary of Product Characteristics for Duodopa must be fulfilled.
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
1. Patients suffering from other diseases that, in the opinion of the Investigator, might interfere with the study objectives.
2. Patients that, in the opinion of the Investigator, are unable to comply with study requirements.
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