N/A
Completed N=2,195
Transdermal Rotigotine User Surveillance Study
Idiopathic Parkinson Disease
Source: ClinicalTrials.gov NCT00599339 ↗
Enrolled (actual)
2,195
Serious AEs
19.5%
Results posted
Apr 2015
Primary outcomePrimary: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) — -2.5; -2.5; -2.2; -5.6 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) |
-2.5; -2.5; -2.2; -5.6; 0.2; 0.0 | — |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) |
-0.1; -0.2; -0.1; 0.0; 0.1; -0.1 | — |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) |
-0.1; -0.2; -0.1; -0.1; 0.0; -0.0 | — |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) |
-0.2; 0.5; -0.1; 0.1; 0.1; 0.1 | — |
| SECONDARY Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) |
-0.27; 1.36; -0.15; 0.05; -0.09; -0.26 | — |
| SECONDARY Hoehn & Yahr Stage at Visit 7 (Month 33) |
2; 0; 0; 0; 0; 0 | — |
| SECONDARY Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) |
1; 1; 0; 2; 1; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00599339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.