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The primary objective of this study is to evaluate the perception of pain associated with Parkinson´s Disease in patients who receive Neupro® for the first time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neupro® Treatment | Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member state Germany. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Visit 2 in the Sum Score Calculated From the 4 Items of the Affective Dimension of the Pain Description List (Schmerzbeschreibungsliste SBL, Question 10) of the German Pain Questionnaire | The Pain Description List (SBL, question 10) is part of the validated German Pain Questionnaire (DSF). The SBL consists of a 12 item list of adjectives. Each adjective is ranked from 0 (not applicable) to 3 (exactly applicable). 8 of the 12 adjectives will be used to assess the sensory items of pain and 4 adjectives to describe the affective items of pain. The 8 sensory items are used to assess qualitative description of pain. For the 4 affective pain items, a sum score ranges from 0 (not applicable) to 12 (exactly applicable). Values above 8 can be considered noticeable. | From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II | The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living'. It consists of 13 questions, each ranging from 0 (none) to 4 (severe abnormalities). The sum score of the UPDRS Part II ranges from 0 (normal) to 52 (worst score possible). |
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Inclusion Criteria:
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Patients with pain associated with idiopathic Parkinson´s Disease. Every consecutive, eligible patient to be treated with Neupro® as per physician's decision.
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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 |
|---|---|---|---|---|---|---|
| 61 | Feldbach | Austria | ||||
| 60 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27883297 | Result | Timmermann L, Oehlwein C, Ransmayr G, Frohlich H, Will E, Schroeder H, Lauterbach T, Bauer L, Kassubek J. Patients' perception of Parkinson's disease-associated pain following initiation of rotigotine: a multicenter non-interventional study. Postgrad Med. 2017 Jan;129(1):46-54. doi: 10.1080/00325481.2017.1258953. Epub 2016 Nov 24. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Enrolled Set (ES).
The study started to enroll subjects in May 2012. Overall, 28 sites enrolled 93 patients in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Neupro® Treatment | Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®) |
| Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III | The UPDRS is a scale for the assessment of function in Parkinson's disease. Part III measures 'Motor Function'. It consists of 14 items with 27 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part III ranges from 0 (normal) to 108 (worst score possible). | From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®) |
| Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III | The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living' and Part III 'Motor Function'. They consist of 40 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part II+III ranges from 0 (normal) to 160 (worst score possible). | From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®) |
| Change From Baseline to Visit 2 in the Short-form Parkinson's Disease Questionnaire (PDQ-8) Total Score | The PDQ-8 is a self-administered 8 item questionnaire that assesses the overall health status. The questions will be rated from 0 (never) to 4 (always [or cannot do at all]). The total score ranges from 0 (never) to 32 (always [or cannot do at all]) with lower scores indicating a better health status. | From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®) |
| Linz |
| Austria |
| 16 | Altenholz | Germany |
| 5 | Alzenau in Unterfranken | Germany |
| 22 | Bad Honnef | Germany |
| 26 | Bad Krozingen | Germany |
| 10 | Berlin | Germany |
| 20 | Cologne | Germany |
| 4 | Dresden | Germany |
| 34 | Düsseldorf | Germany |
| 38 | Erbach im Odenwald | Germany |
| 24 | Freiburg im Breisgau | Germany |
| 1 | Gera | Germany |
| 3 | Göttingen | Germany |
| 32 | Hamburg | Germany |
| 2 | Heidenheim | Germany |
| 11 | Königsbrück | Germany |
| 15 | Mühldorf | Germany |
| 33 | Münster | Germany |
| 35 | Osnabrück | Germany |
| 31 | Rüsselsheim am Main | Germany |
| 7 | Schriesheim | Germany |
| 44 | Senftenberg | Germany |
| 12 | Stadtroda | Germany |
| 13 | Ulm | Germany |
| 41 | Westerstede | Germany |
| 37 | Würzburg | Germany |
| Safety Set |
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| Full Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristics refer to the Safety Set, including all enrolled patients who had applied the rotigotine transdermal patch at least once.
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| ID | Title | Description |
|---|---|---|
| BG000 | Neupro® Treatment | Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 2 in the Sum Score Calculated From the 4 Items of the Affective Dimension of the Pain Description List (Schmerzbeschreibungsliste SBL, Question 10) of the German Pain Questionnaire | The Pain Description List (SBL, question 10) is part of the validated German Pain Questionnaire (DSF). The SBL consists of a 12 item list of adjectives. Each adjective is ranked from 0 (not applicable) to 3 (exactly applicable). 8 of the 12 adjectives will be used to assess the sensory items of pain and 4 adjectives to describe the affective items of pain. The 8 sensory items are used to assess qualitative description of pain. For the 4 affective pain items, a sum score ranges from 0 (not applicable) to 12 (exactly applicable). Values above 8 can be considered noticeable. | Full Analysis Set (FAS). The FAS includes all enrolled patients who had applied the rotigotine transdermal patch at least once and for whom valid data for the primary effectiveness variable were available from Baseline and a subsequent routine visit. | Posted | Mean | Standard Deviation | units on a scale | From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®) |
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| Secondary | Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II | The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living'. It consists of 13 questions, each ranging from 0 (none) to 4 (severe abnormalities). The sum score of the UPDRS Part II ranges from 0 (normal) to 52 (worst score possible). | Of the 70 patients in the Full Analysis Set (FAS), 68 patients had complete data for UPDRS Part II and are included in the analysis of this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®) |
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| Secondary | Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III | The UPDRS is a scale for the assessment of function in Parkinson's disease. Part III measures 'Motor Function'. It consists of 14 items with 27 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part III ranges from 0 (normal) to 108 (worst score possible). | Of the 70 patients in the Full Analysis Set (FAS), 67 patients had complete data for UPDRS Part III and are included in the analysis of this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®) |
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| Secondary | Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III | The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living' and Part III 'Motor Function'. They consist of 40 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part II+III ranges from 0 (normal) to 160 (worst score possible). | Of the 70 patients in the Full Analysis Set (FAS), 68 patients had complete data for UPDRS Part II and 67 patients had complete data for UPDRS Part III. Thus, of the 70 patients in the FAS, 67 patients are included in the analysis of this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®) |
|
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| Secondary | Change From Baseline to Visit 2 in the Short-form Parkinson's Disease Questionnaire (PDQ-8) Total Score | The PDQ-8 is a self-administered 8 item questionnaire that assesses the overall health status. The questions will be rated from 0 (never) to 4 (always [or cannot do at all]). The total score ranges from 0 (never) to 32 (always [or cannot do at all]) with lower scores indicating a better health status. | Full Analysis Set (FAS). The FAS includes all enrolled patients who had applied the rotigotine transdermal patch at least once and for whom valid data for the primary effectiveness variable were available from Baseline and a subsequent routine visit. | Posted | Mean | Standard Deviation | units on a scale | From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®) |
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Adverse Events were collected over the whole study from Visit 1 (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro).
Since this was a NIS with no safety objectives, only the related adverse events (AEs), ie, adverse drug reactions (ADRs), were documented.
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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 | Neupro® Treatment | Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria. | 0 | 93 | 10 | 93 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VERTIGO | Ear and labyrinth disorders | MedDRA 17.0 | Non-systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| APPLICATION SITE ERYTHEMA | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| APPLICATION SITE HYPERSENSITIVITY | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| HALLUCINATION | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
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| HALLUCINATION, VISUAL | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
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| SLEEP DISORDER | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| PRURITUS GENERALISED | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| GENERALISED ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
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| 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 |
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