Transdermal Rotigotine User Surveillance Study

Completed

• Conditions: Idiopathic Parkinson Disease

• Registration Number: NCT00599339
• Lead Sponsor: UCB Pharma

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 Timeline

• Study Start: 2006-06
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-23
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-04-10
• Results First Submitted QC: 2015-04-10
• Results First Posted: 2015-04-29
• Status Verified: 2015-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2195

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)	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 Outcome Measures

Name	Time	Method
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)	The Unified Parkinson's disease rating scale (UPDRS) question 32 of part IV asks. "What Proportion of the waking day are dyskinesias present?" Answers range from 0 (None) to 4 (76-100 % of the day).
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)	The Unified Parkinson's disease rating scale (UPDRS) Part IV question 33 asks for complications of therapy in the past week, through the question "How disabling are the dyskinesias ? " Answers range from 0 (Not disabling) to 4 (Completely disabling).
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)	33 months	The Unified Parkinson's disease rating scale (UPDRS) Part IV question 39 asks "What proportion of the waking day is the patient "off", on average?" Answers range from 0 (None) to 4 (76-100 % of the day).
Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)	33 months	The NADCS assesses sleep-related motor complaints including nocturnal akinesia, dystonia and painful cramps by an ordinal severity scale.; The NADCS total score ranges from 0 (normal) to 4 (maximum severity). NADCS value was missing for one subject at Visit 7.
Hoehn & Yahr Stage at Visit 7 (Month 33)	33 months	The Hoehn and Yahr staging of Parkinson's disease in the "on" stage, if applicable, had to be completed by the physician.; Possible staging: * 0 No signs of disease; * 1 Unilateral disease; * 2 Bilateral disease without impairment of balance; * 3 Mild to moderate bilateral disease, some postural instability, physically dependent; * 4 Severe disability, still able to walk or stand unassisted; * 5 Wheelchair bound or bedridden unless aided
Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)	33 months	The analysis was performed for the non-disjunctive classification into patients at risk to develop an Adverse Event associated with Rotigotine and patients at risk to develop an Adverse Event not associated with Rotigotine.

Trial Locations

Locations (211)

813; 🇨🇿 Chomutov, Czechia

808; 🇨🇿 Hradec Kralove, Czechia

822; 🇨🇿 Hradec Kralove, Czechia

811; 🇨🇿 Litomysl, Czechia

803; 🇨🇿 Ostrava-Poruba, Czechia

809; 🇨🇿 Pardubice, Czechia

817; 🇨🇿 Pisek, Czechia

814; 🇨🇿 Plzen-Lochotin, Czechia

829; 🇨🇿 Praha 10, Czechia

805; 🇨🇿 Praha 1, Czechia

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