Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study intends to collect data on gastrointestinal symptoms (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, diarrhea) and on patient satisfaction under everyday practice conditions after changing treatment to Neupro® transdermal patch in patients suffering from idiopathic Parkinson´s Disease with gastrointestinal symptoms while being treated with oral antiparkinson drugs. The objective of the study is to ascertain whether switching therapy to Neupro® transdermal patch can provide any relief in gastrointestinal symptoms.
Routine treatment as per approved label in Europe in accordance with the terms of the local marketing authorization for Neupro®.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neupro | Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS) | Patients were asked to classify the intensity of their GI complaints on a scale ranging from 0 (no complaints) to 100 (extremely severe complaints). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement. | From Baseline to Visit 3 (approximately 6 weeks) |
| Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints | Sum score of GI complaints was calculated from frequency and intensity of the complaints. The intensity of GI complaints during the last week ranges from 0 (no complaints) to 3 (severe) and the frequency of these complaints during the last week ranges from 0 (never) to 4 (every day). For each of the seven GI complaints assessed at a visit (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, and diarrhea), intensity and frequency were multiplied to achieve individual item scores of GI complaints (range: 0 - 12). Finally, the sum score of GI complaints per visit was calculated by accumulating 6 of the 7 item scores (excluding swallowing disorders, which was recorded at Baseline only) for patients with valid values in each score (range: 0 - 72). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement. | From Baseline to Visit 3 (approximately 6 weeks) |
| Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 | Patient satisfaction referring to GI complaints is classified into 5 categories:
| At Visit 2 (after approximately 2-4 weeks) |
| Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 | Patient satisfaction referring to GI complaints is classified into 5 categories:
|
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not applicable
Not provided
Not provided
Not provided
Not provided
Patients with Parkinson's Disease (PD) suffering from gastrointestinal complaints under oral anti-parkinson treatment; treated in Germany by neurological outpatient centers (clinic/ practice of neurologist).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 02 | Berlin | Germany | ||||
| 24 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25595315 | Derived | Woitalla D, Kassubek J, Timmermann L, Lauterbach T, Berkels R, Grieger F, Muller T. Reduction of gastrointestinal symptoms in Parkinson's disease after a switch from oral therapy to rotigotine transdermal patch: a non-interventional prospective multicenter trial. Parkinsonism Relat Disord. 2015 Mar;21(3):199-204. doi: 10.1016/j.parkreldis.2014.11.024. Epub 2014 Dec 4. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
76 patients were included in the Enrolled Set (ES), 75 of whom were treated with Neupro® at least once during the Observational Period and, thus, constituted the Safety Set (SS). The Full Analysis Set (FAS) encompassed all 65 patients who had been treated with Neupro® at least once and who had valid Baseline and Follow-up Visit values.
This study started to enroll subjects in June 2010 in order to end up with 21 centers in Germany.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Neupro | Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| At Visit 3 (after approximately 6 weeks) |
| Bochum |
| Germany |
| 38 | Buchholz | Germany |
| 7 | Cologne | Germany |
| 30 | Erbach im Odenwald | Germany |
| 14 | Gera | Germany |
| 28 | Göttingen | Germany |
| 16 | Karlstadt am Main | Germany |
| 40 | Lauf an der Pegnitz | Germany |
| 39 | Lüneburg | Germany |
| 37 | München | Germany |
| 31 | Neuburg am Inn | Germany |
| 35 | Nuremberg | Germany |
| 22 | Schriesheim | Germany |
| 34 | Schwäbisch Gmünd | Germany |
| 21 | Stadtroda | Germany |
| 12 | Stuttgart | Germany |
| 36 | Stuttgart | Germany |
| 1 | Ulm | Germany |
| 32 | Ulm | Germany |
| 29 | Wolfratshausen | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics show the Enrolled Set (ES). ES encompasses those patients who have been included in this study and for whom data are available on the first Visit (initial examination).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Neupro | Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch. |
| 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 | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||||||
| Height | Mean | Standard Deviation | centimeter (cm) |
|
| 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 | Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS) | Patients were asked to classify the intensity of their GI complaints on a scale ranging from 0 (no complaints) to 100 (extremely severe complaints). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement. | Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis. | Posted | Mean | Standard Deviation | millimeter (mm) | From Baseline to Visit 3 (approximately 6 weeks) |
|
|
| |||||||||||||||||||||||||
| Primary | Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints | Sum score of GI complaints was calculated from frequency and intensity of the complaints. The intensity of GI complaints during the last week ranges from 0 (no complaints) to 3 (severe) and the frequency of these complaints during the last week ranges from 0 (never) to 4 (every day). For each of the seven GI complaints assessed at a visit (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, and diarrhea), intensity and frequency were multiplied to achieve individual item scores of GI complaints (range: 0 - 12). Finally, the sum score of GI complaints per visit was calculated by accumulating 6 of the 7 item scores (excluding swallowing disorders, which was recorded at Baseline only) for patients with valid values in each score (range: 0 - 72). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement. | Of the 65 subjects in the Full Analysis Set, 58 are included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to Visit 3 (approximately 6 weeks) |
|
| ||||||||||||||||||||||||||
| Primary | Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2 | Patient satisfaction referring to GI complaints is classified into 5 categories:
| All of the 65 subjects in the Full Analysis Set are included in this analysis. | Posted | Number | participants | At Visit 2 (after approximately 2-4 weeks) |
|
| |||||||||||||||||||||||||||
| Primary | Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3 | Patient satisfaction referring to GI complaints is classified into 5 categories:
| All of the 65 subjects in the Full Analysis Set are included in this analysis. | Posted | Number | participants | At Visit 3 (after approximately 6 weeks) |
|
|
Adverse Events (AEs) were collected over the entire Study Period from Baseline (Visit 1) up to approximately 6 weeks (Visit 3).
Adverse Events refer to the Safety Set. The Safety Set encompasses all included patients who were treated with Neupro® at least once. Of the 76 patients in the Enrolled Set, 75 patients are included in the Safety Set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neupro | Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch. | 4 | 75 | 21 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haematoma evacuation | Surgical and medical procedures | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lacrimation increased | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| On and off phenomenon | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 (UCB) |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
|
|
|
|