NCT00599339CompletedNot Applicable
A Naturalistic, Multisite, Observational Study of Rotigotine Transdermal Patch and Other Currently Prescribed Therapies in Patients With Idiopathic Parkinson's Disease
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- UCB Pharma
- Enrollment
- 2,195
- Locations
- 211
- Primary Endpoint
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)
Study Overview
Brief Summary
This study will be conducted in an observational multiple-cohort design aimed at acquiring clinical, treatment, health status, and economic data. Patients with Parkinson's disease (PD) will be enrolled.
Detailed Description
All patients attending the physician and fulfilling the eligibility criteria are included.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with idiopathic early-stage Parkinson's Disease requiring dopaminergic monotherapy (rotigotine, other dopamine agonists or levodopa) at study onset
- •Patients with advanced-stage Parkinson's Disease requiring dopaminergic therapy with levodopa in combination with rotigotine or other dopamine agonists at study onset
Exclusion Criteria
- •Patients who are unable to comply with study requirements
Outcomes
Primary Outcomes
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)
Time Frame: From Baseline to Visit 7 (Month 33)
The Unified Parkinson's disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome).
Secondary Outcomes
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)(From Baseline to Visit 7 (Month 33))
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33)(From Baseline to Visit 7 (Month 33))
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)(33 months)
- Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)(33 months)
- Hoehn & Yahr Stage at Visit 7 (Month 33)(33 months)
- Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)(33 months)
Investigators
Study Sites (211)
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