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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005438-19 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Rotigotine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine | Drug | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Rotigotine After Use. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augsburg | Germany | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20535621 | Result | Wullner U, Kassubek J, Odin P, Schwarz M, Naumann M, Hack HJ, Boroojerdi B, Reichmann H; NEUPOS Study Group. Transdermal rotigotine for the perioperative management of Parkinson's disease. J Neural Transm (Vienna). 2010 Jul;117(7):855-9. doi: 10.1007/s00702-010-0425-4. Epub 2010 Jun 10. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotigotine | Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotigotine | Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Full Analysis Set (Subjects having valid data for all three feasibility assessments) | Mean | Standard Deviation | Score on scale | After subject wakes up from general anesthesia |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rotigotine | Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular asystole | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | +1 877 822 9493 |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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|
| Bochum |
| Germany |
| Bonn | Germany |
| Bremerhaven | Germany |
| Dortmund | Germany |
| Dresden | Germany |
| Hanau | Germany |
| Ingolstadt | Germany |
| Kiel | Germany |
| Schwerin | Germany |
| Stralsund | Germany |
| Ulm | Germany |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Plasma Concentration of Rotigotine After Use. | 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) | Mean | Standard Deviation | ng/ml | 24 hours |
|
|
|
| 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 | Full Analysis Set (Subjects having valid data for all three feasibility assessments) | Mean | Standard Deviation | Score on scale | 2 weeks after surgery |
|
|
|
| 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 | Full Analysis Set (Subjects having valid data for all three feasibility assessments) | Mean | Standard Deviation | Score on scale | 2 weeks after surgery |
|
|
|
| 4 |
| 14 |
| 10 |
| 14 |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
|
| Urine uric acid increased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Dysaesthesia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Dementia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |