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The objective is to assess the effect of Neupro® on the severity of Restless Leg Syndrome (RLS) symptoms and augmentation in patients with augmentation associated with previous oral dopaminergic therapy. In addition, the change in treatment regimen used when switching to Neupro® will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neupro® Treatment | Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1. | From Baseline up to 7 days |
| Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 3 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
A negative change from Baseline to Visit 3 indicates an improvement in CGI Item 1. | From Baseline up to 28 days |
| Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 4 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
A negative change from Baseline to Visit 4 indicates an improvement in CGI Item 1. | From Baseline up to 4 months |
| Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 5 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Treatment Regimen Used for Switching to Neupro® up to 28 Days After Entering in the Study | Case reports from clinical practice refer to different switching regimens for patients taking oral dopaminergics who experienced augmentation and then switched to Neupro®. The previous dopaminergic treatment might have been partly or completely down-titrated prior to switching to Neupro®. Physicians were requested to document the change of treatment at each recommended visit in the electronic Case Report Form (eCRF) considering their total clinical experience with this particular Restless Legs Syndrome (RLS) patients population. Documentation comprised changes in the RLS medication last prescribed, and the dosage of Neupro® and concomitant medications. The change of treatment regimen was entirely at the physicians' discretion. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patient with a diagnosis of moderate to severe idiopathic Restless Leg Syndrome (RLS).
Patient must be experiencing augmentation due to a prior dopaminergic treatment.
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 |
|---|---|---|---|---|---|---|
| 12 | Berlin | Germany | ||||
| 4 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26896370 | Result | Trenkwalder C, Canelo M, Lang M, Schroeder H, Kelling D, Berkels R, Schollmayer E, Heidbrede T, Benes H. Management of augmentation of restless legs syndrome with rotigotine: a 1-year observational study. Sleep Med. 2017 Feb;30:257-265. doi: 10.1016/j.sleep.2015.10.006. Epub 2015 Nov 11. |
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The physician was to decide freely to treat the patient with Neupro®. In this context, the physician was not to change routine practice in reaching treatment decisions and in treating his/her patients because of the study. The observational period was 13 months per patient (adjustment period of medication switch plus 12 months of observation).
This non-interventional study (NIS) was conducted in 18 specialized centres (medical practice and outpatient department) for neurology throughout Germany.
The Participant Flow refers to the Enrolled Set (ES). The ES consists of all patients who provided informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Neupro® Treatment | Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| From Baseline up to 7 months |
| Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
A negative change from Baseline to Visit 6 indicates an improvement in CGI Item 1. | From Baseline up to 10 months |
| Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 7 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
A negative change from Baseline to Visit 7 indicates an improvement in CGI Item 1. | From Baseline up to 13 months |
| From Baseline up to 28 days |
| Bremen |
| Germany |
| 18 | Dresden | Germany |
| 20 | Flensburg | Germany |
| 1 | Kassel | Germany |
| 11 | Marburg | Germany |
| 17 | Marburg | Germany |
| 2 | Mönchengladbach | Germany |
| 6 | Münster | Germany |
| 7 | Regensburg | Germany |
| 21 | Remscheid | Germany |
| 15 | Schriesheim | Germany |
| 10 | Schwalmstadt | Germany |
| 3 | Schwerin | Germany |
| 8 | Tübingen | Germany |
| 16 | Ulm | Germany |
| 9 | Ulm | Germany |
| 19 | Westerstede | Germany |
| COMPLETED |
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| NOT COMPLETED |
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The Baseline Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.
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| ID | Title | Description |
|---|---|---|
| BG000 | Neupro® Treatment | Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU). |
| 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, Continuous | Mean | Standard Deviation | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Height | Mean | Standard Deviation | centimeter |
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| Weight | Mean | Standard Deviation | kilogram |
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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 (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1. | The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented. | Posted | Mean | Standard Deviation | score on a scale | From Baseline up to 7 days |
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| Primary | Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 3 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
A negative change from Baseline to Visit 3 indicates an improvement in CGI Item 1. | The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented. | Posted | Mean | Standard Deviation | score on a scale | From Baseline up to 28 days |
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| Primary | Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 4 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
A negative change from Baseline to Visit 4 indicates an improvement in CGI Item 1. | The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented. | Posted | Mean | Standard Deviation | score on a scale | From Baseline up to 4 months |
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| Primary | Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 5 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1. | The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented. | Posted | Mean | Standard Deviation | score on a scale | From Baseline up to 7 months |
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| Primary | Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
A negative change from Baseline to Visit 6 indicates an improvement in CGI Item 1. | The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented. | Posted | Mean | Standard Deviation | score on a scale | From Baseline up to 10 months |
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| Primary | Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 7 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:
A negative change from Baseline to Visit 7 indicates an improvement in CGI Item 1. | The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented. | Posted | Mean | Standard Deviation | score on a scale | From Baseline up to 13 months |
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| Secondary | Change in Treatment Regimen Used for Switching to Neupro® up to 28 Days After Entering in the Study | Case reports from clinical practice refer to different switching regimens for patients taking oral dopaminergics who experienced augmentation and then switched to Neupro®. The previous dopaminergic treatment might have been partly or completely down-titrated prior to switching to Neupro®. Physicians were requested to document the change of treatment at each recommended visit in the electronic Case Report Form (eCRF) considering their total clinical experience with this particular Restless Legs Syndrome (RLS) patients population. Documentation comprised changes in the RLS medication last prescribed, and the dosage of Neupro® and concomitant medications. The change of treatment regimen was entirely at the physicians' discretion. | The Analysis Population refers to the Eligibility Completer Set (ECS). The ECS is a subset of the Completer Set excluding patients with Parkinson's disease and/or treated Polyneuropathy as concomitant disease identified by the preferred term (PT) of the MedDRA coding and patients treated with Neupro up to 4 weeks before Visit 1. | Posted | Number | participants | From Baseline up to 28 days |
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Adverse Events were reported from Day 1 up to 13 months.
The Analysis Population refers to the Safety Set (SS). The Safety Set (SS) consists of all patients who have signed the consent form and who received treatment with Neupro at least once. Every Adverse Event occurring during the conduct of the study had to be entered in the respective electronic AE/SAE documentation form irrespective of causality.
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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 (1,2,3 mg/24 h) as per approved label in the European Union (EU). | 9 | 99 | 40 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Diverticulum | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Acquired oesophageal web | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Irritability | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Personality change | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Acute stress disorder | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Thinking abnormal | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Micturition urgency | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Thyroidectomy | Surgical and medical procedures | MedDRA 14.0 | Non-systematic Assessment |
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| Arterial thrombosis limb | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Application site erythema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Application site reaction | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Application site pruritus | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | ++1 877 822 9493 |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
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| >=65 years |
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| Missing |
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