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

UCB Pharma14 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson's Disease

Interventions

RotigotineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (12)

Unnamed facility

Augsburg, Germany

Unnamed facility

Bochum, Germany

Unnamed facility

Bonn, Germany

Unnamed facility

Bremerhaven, Germany

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 2 weeks after surgery

Secondary Outcomes

Plasma Concentration of Rotigotine After Use.

Time frame: 24 hours

Data from ClinicalTrials.gov

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