An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage 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 safety and tolerability of long-term treatment of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease.

Detailed Description
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This is the open-label extension to the randomized, double-blind, placebo-controlled SP650 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease who are not well-controlled on Levodopa.

Official Title
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An Open-Label Extension to the Double-Blind SP650 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage 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: Subjects who have completed six months of maintenance treatment in the SP650 double-blind trial Exclusion Criteria: Subjects who had an ongoing serious adverse event from the SP650 double-blind trial that was assessed as related to study medication

Ages Eligible for Study
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Minimum Age: 31 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> | Drug: Rotigotine<br>* Rotigotine transdermal patches: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) Optimal dosing: During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours. After the first year: Allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.<br>* Other names: Neupro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With at Least One Adverse Event During This Open-label Extension Study | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Withdrew From the Trial Due to an Adverse Event. | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | 6 years | 
| Mean Epworth Sleepiness Scale Score During the Open-label Extension. | The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness. | Visit 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (end of year 6), End of Treatment (last study visit or early withdrawal visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotigotine, Neupro