Parkinson's Disease
Conditions
Keywords
Rotigotine, NEUPRO®, Parkinson's Disease (PD), perioperative use, anaesthesia,
Brief summary
Evaluation of efficacy and safety on the use of rotigotine in patients suffering from Parkinson's Disease during and after surgery requiring general anaesthesia.
Interventions
DRUGRotigotine
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.
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist. | After subject wakes up from general anesthesia | 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 |
| Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist. | 2 weeks after surgery | 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 |
| Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient. | 2 weeks after surgery | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Plasma Concentration of Rotigotine After Use. | 24 hours |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rotigotine Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Delay in operation | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Rotigotine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 68.7 years STANDARD_DEVIATION 5.9 |
| Region of Enrollment Germany | 14 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 14 |
| serious Total, serious adverse events | 4 / 14 |
Outcome results
Primary
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
Population: Full Analysis Set (Subjects having valid data for all three feasibility assessments)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Anaesthesiologist. | 5.0 Score on scale | Standard Deviation 1.8 |
Primary
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
Population: Full Analysis Set (Subjects having valid data for all three feasibility assessments)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Neurologist. | 5.2 Score on scale | Standard Deviation 2.2 |
Primary
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
Population: Full Analysis Set (Subjects having valid data for all three feasibility assessments)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Efficacy and Safety of Rotigotine Used During Surgery Under General Anaesthesia Assessed by Patient. | 3.9 Score on scale | Standard Deviation 1.4 |
Secondary
Plasma Concentration of Rotigotine After Use.
Time frame: 24 hours
Population: Pharmacokinetic Set (Subjects for whom a blood sample for determination of the plasma concentration of rotigotine was drawn and a valid determination of the plasma concentration could be done)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Plasma Concentration of Rotigotine After Use. | 0.1640 ng/ml | Standard Deviation 0 |
| Rotigotine 6mg/24h | Plasma Concentration of Rotigotine After Use. | 0.2480 ng/ml | Standard Deviation 0 |
| Rotigotine 8 mg/24h | Plasma Concentration of Rotigotine After Use. | 0.7570 ng/ml | Standard Deviation 0.1569 |
| Rotigotine 12 mg/24h | Plasma Concentration of Rotigotine After Use. | 0.8405 ng/ml | Standard Deviation 0.3302 |
| Rotigotine 14 mg/24h | Plasma Concentration of Rotigotine After Use. | 0.8689 ng/ml | Standard Deviation 0 |
| Rotigotine 16 mg/24h | Plasma Concentration of Rotigotine After Use. | 1.6958 ng/ml | Standard Deviation 2.1951 |