A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing Surgery

Study Overview
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Brief Summary
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Evaluation of efficacy and safety on the use of rotigotine in patients suffering from Parkinson's Disease during and after surgery requiring general anaesthesia.

Official Title
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An Explorative, Multicenter, Open-label Pilot Trial With Neupro® (Rotigotine Transdermal Patch) Once Daily Treatment Administered Perioperatively in Patients 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: Subject has idiopathic Parkinson's disease (early- or advanced-stage), as defined by the cardinal sign bradykinesia, plus the presence of at least one of the following: resting tremor, rigidity, or postural instability and is without any other known or suspected cause of Parkinsonism. Subject is scheduled for an operation requiring general anesthesia. Exclusion Criteria: Subject has previously been treated with rotigotine. Subject has a history of significant skin hypersensitivity to adhesives or other transdermals or recent unresolved contact dermatitis or has a known allergy or hypersensitivity to rotigotine or to other components of the patch. Subject is scheduled for a surgical procedure (surgery per protocol(SPP)) that requires magnetic resonance imaging or cardioversion. Subject has a high probability to require extended postoperative ventilation (> 24 hours). Subject has any medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's ability to participate in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: 1<br>Rotigotine | Drug: Rotigotine<br>* 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h patch; Single patches and a combination of 2 of these patches for a dosage of up to 16 mg/24 h; One (1) regimen on day of surgery, but exceptionally extended for up to 2 (two) weeks if the patient requires unexpected ventilation after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist. | Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Patient did not show unexpected symptoms Item 2: Handling was simple Item 3: Handling wasn't time-consuming Item 4: Patch is a considerable option | After subject wakes up from general anesthesia | 
| Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist. | Questionnaire including 4 items Range of sum score: 4 to 24 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Switch to patch was easily feasible Item 2: Re-switch was easily feasible Item 3: Patient did not show unexpected symptoms Item 4: Patch is a feasible option | 2 weeks after surgery | 
| Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient. | Questionnaire including 3 items Range of sum score: 3 to 18 Range of item scores: 1 (I agree completely) to 6 (I don't agree at all) Item 1: Therapy with patch was easily feasible Item 2: Symptoms of Parkinson's Disease were well controlled Item 3: I felt safe with the Parkinson patch | 2 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of Rotigotine After Use. |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotigotine, NEUPRO®, Parkinson's Disease (PD), perioperative use, anaesthesia,