First Presentation of Parkinson Disease Patients to Neurologist
- Conditions
- Parkinson Disease
- Registration Number
- NCT00802178
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
In this study information is gathered about the treatment of Parkinson patients who present themselves in a neurological practice for the first time
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2448
- Parkinson Disease patients presenting to neurologist for first time
- Hypersensitivity to the active substance or to any of the excipients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated 4 - 8 weeks Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.
De-novo patients were identified by:
those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy)
- Secondary Outcome Measures
Name Time Method Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Baseline and 4 to 8 weeks Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability)
Change From Baseline in UPDRS Part III Baseline and 4 - 8 weeks Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability).
Global Clinical Assessments of Efficacy of Mirapexin® for All Patients 4 - 8 weeks Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.
Trial Locations
- Locations (27)
Boehringer ingelheim Investigational Site 2
🇸🇮Maribor, Slovenia
Boehringer ingelheim Investigational Site 3
🇸🇮Maribor, Slovenia
Boehringer Ingelheim Investigational Site 8
🇷🇴Bucuresti, Romania
Boehringer ingelheim Investigational Site 4
🇸🇮Maribor, Slovenia
Boehringer Ingelheim Investigational Site
🇸🇰Vranov nad Topľou, Slovakia
Boehringer Ingelheim Investigational Site 2
🇸🇰Zilina, Slovakia
Boehringer Ingelheim Investigational Site 3
🇸🇰Kosice, Slovakia
Boehringer Ingelheim Investigational Site 4
🇸🇰Kosice, Slovakia
Boehringer Ingelheim Investigational Site 7
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 10
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 13
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 16
🇷🇴Bucuresti, Romania
Boehringer ingelheim Investigational Site 1
🇸🇮Sempeter pri Gorici, Slovenia
Boehringer Ingelheim Investigational Site 1
🇸🇰Zilina, Slovakia
Boehringer Ingelheim Investigational Site 11
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 17
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 6
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 9
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 14
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 15
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 18
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 19
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 21
🇷🇴Bucuresti, Romania
Boehringer ingelheim Investigational Site 5
🇸🇮Ljubljana, Slovenia
Boehringer Ingelheim Investigational Site 12
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 20
🇷🇴Bucuresti, Romania
Boehringer Ingelheim Investigational Site 5
🇸🇰Kosice- Saca, Slovakia