Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease

Study Overview
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Brief Summary
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The objective of this open-label extension is to assess the long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated.

Official Title
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A Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Rotigotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completion of trial SP889 Exclusion Criteria: Ongoing serious adverse event assessed as related to trial medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotigotine<br>Rotigotine Transdermal Patch | Drug: Rotigotine<br>* Rotigotine transdermal patches: 10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h) Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h<br>* Other names: Neupro®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance) | The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. Baseline is defined as first titration visit (T1) of SP915. | Baseline (baseline SP915) and week 13 (End of maintenance) | 
| Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance) | The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often. Baseline is defined as Visit 2 of previous double- blind trial SP889. | Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance) | Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep. Baseline is defined as Visit 2 of previous double- blind trial SP889. | Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) | 
| Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance) | The change in number of nocturias was used to evaluate improvements in sleep disorders. Baseline is defined as Visit 2 of previous double- blind trial SP889. | Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neupro®, Rotigotine, Parkinson's Disease