Disease progression in Patients with Parkinson’s disease uncontrolled on oral medication – a prospective, multicenter, observational study to assess health related quality of life over 24 months in Germany
- Conditions
- G20Parkinson disease
- Registration Number
- DRKS00032062
- Lead Sponsor
- euroTransData GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 258
• male, female, or non-binary
• Patients with confirmed idiopathic Parkinson’s disease
• Using oral levodopa treatment
• Patients with Parkinson’s disease in MANAGE PD categories 2 and 3
• Willingness to sign and date a Patient Authorization Form to use and disclose personal health information (or informed consent form if required)
• Being able to speak and understand the language of the provided patient questionnaire
• Participation in a concurrent clinical study
• Patients with Parkinson’s disease in MANAGE PD category 1
• Significant uncertainty around the diagnosis of PD (i.e. symptoms present such as early falls or early autonomic disturbances or lack of levodopa responsiveness)
• Current or past treatment with a device aided therapy (eg, LCIG, LECIG, CSAI, DBS) at baseline.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in PDQ-8 of Patients with Parkinson’s disease uncontrolled on current oral medication (MANAGE PD category 2 and 3) from baseline visit to month 24.<br>
- Secondary Outcome Measures
Name Time Method