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This is a Phase 3b, open-label, multicenter trial to assess the safety and tolerability of switching from ropinirole therapy to the rotigotine transdermal system and its effect on symptoms in subjects with idiopathic Parkinson's disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotigotine | Experimental | Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine | Drug | Strength: 2,4,6,and 8mg/24h, form: transdermal application, once daily application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulse Rate (Supine, After 1 Minute) | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Systolic Blood Pressure (Supine, After 1 Minute) | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Diastolic Blood Pressure (Supine, After 1 Minute) | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Pulse Rate (Supine, After 5 Minutes) | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Systolic Blood Pressure (Supine, After 5 Minutes) | Change = 28 day value minus baseline value. | Baseline, 28 Days |
| Change in Diastolic Blood Pressure (Supine, After 5 Minutes) | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Pulse Rate (Standing, After 1 Minute) | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Systolic Blood Pressure (Standing, After 1 Minute) | Change = 28 day value minus baseline value. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment | The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part I measures 'Mentation, Behavior and Mood'. Range: 0 (Best score possible) to 16 (Worst score possible) Change = 28 day value minus baseline value. | Baseline, 28 days |
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Inclusion Criteria:
Exclusion Criteria:
Subjects are not permitted to enroll in the trial if any of the following criteria are met:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21831297 | Result | Kim HJ, Jeon BS, Lee WY, Lee MC, Kim JW, Kim JM, Ahn TB, Cho J, Chung SJ, Grieger F, Whitesides J, Boroojerdi B. Overnight switch from ropinirole to transdermal rotigotine patch in patients with Parkinson disease. BMC Neurol. 2011 Aug 10;11:100. doi: 10.1186/1471-2377-11-100. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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124 patients were screened. 5 patients were run-in failures and 3 patients were screen failures. 116 patients started treatment, i.e. were included into the Safety Set. 114 patients were included into the Full Analysis Set. 99 patients completed the treatment period. 2 patients withdrew after the treatment period. 97 patients completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotigotine | Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotigotine | Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking. |
| 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 | Change in Pulse Rate (Supine, After 1 Minute) | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | beats per minute | Baseline, 28 days |
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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 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +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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| Baseline, 28 days |
| Change in Diastolic Blood Pressure (Standing, After 1 Minute) | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Pulse Rate (Standing, After 3 Minutes) | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Systolic Blood Pressure (Standing, After 3 Minutes) | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Diastolic Blood Pressure (Standing, After 3 Minutes) | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Heart Rate | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in PR Interval | The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization (beginning of the QRS complex). Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in QRS Duration | The QRS duration represents the time it takes for ventricular depolarization to occur. Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in QT Interval | The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) | The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Percentage of Basophilic Granulocytes in White Blood Cell Count | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Hematocrit | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Hemoglobin | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Percentage of Lymphocytes in White Blood Cell Count | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Percentage of Monocytes in White Blood Cell Count | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Platelet Count | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Red Blood Cell Count | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in White Blood Cell Count | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Albumin | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Alkaline Phosphatase | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Blood Urea Nitrogen | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Calcium | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Chloride | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Creatinine | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Gamma-Glutamyltransferase | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Glucose | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Inorganic Phosphate | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Potassium | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Serum Glutamic Oxaloacetic Transaminase | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Glutamic Pyruvic Transaminase | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Sodium | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Total Bilirubin | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Total Protein | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Uric Acid | Change = 28 day value minus baseline value. | Baseline, 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception' | 28 days |
| Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other' | 28 days |
| Completion of Trial From Baseline to End of Treatment | Baseline, 28 days |
| Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment | Baseline, 28 days |
| Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs) | Baseline, 2 days |
| Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period | Baseline, 56 days |
| Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs) | Baseline, 2 days |
| Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period | Baseline, 56 days |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment | The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part II measures 'Activities in Daily Living'. Range: 0 (Best score possible) to 52 (Worst score possible) Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment | The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part III measures 'Motor Examination'. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment | The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part IV measures 'Complications of Therapy'. Range: 0 (Best score possible) to 23 (Worst score possible) Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment | The PDSS is a scale to assess sleep and nocturnal disability in Parkinson's disease. Range: 0 (Best score possible) to 60 (Worst score possible) Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment | The ESS is a self-administered questionnaire in which the subject rates the probability of his/her dozing during 8 situations that are differently conductive to sleep Range: 0 (Best score possible) to 24 (Worst score possible) Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment | The PDNMS is a rating by the clinician to assess the severity and frequency of non-motor symptoms in Parkinson's disease patients Range: 0 (Best score possible) to 384 (Worst score possible) Change = 28 day value minus baseline value. | Baseline, 28 days |
| Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment | The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 1 measures 'Severity of Parkinson's Disease'. Range: 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients) Change = 28 day value minus baseline value. | Baseline, 28 days |
| Clinical Global Impression (CGI) Item 2 Score | The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 2 measures 'Global Improvement'. Range 1 (Very much improved) to 7 (Very much worse) | 28 days |
| Clinical Global Impression (CGI) Item 3.1 | The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 3.1 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms.) to 4 (Unchanged or worse) | 28 days |
| Clinical Global Impression (CGI) Item 3.2 | The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 3.2 measures 'Therapeutic Side Effects'. Range: 1 (None) to 4 (Outweigh the therapeutic effect) | 28 days |
| Patient Global Impression (PGI) Item 1 Score | The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 1 measures 'Global Improvement'. Range: 1 (Very much improved) to 7 (Very much worse) | 28 days |
| Patient Global Impression (PGI) Item 2 | The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 2 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms) to 4 (Unchanged or worse) | 28 days |
| Patient Global Impression (PGI) Item 3 | The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 3 measures 'Side Effects'. Range: 1 (I have no side effects) to 4 (They outweigh the therapeutic effect of the trial medication) | 28 days |
| Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment | The PDQ-8 is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease. Range: 0 (good health) to 100 (poor health) Change = 28 day value minus baseline value. | Baseline, 28 days |
| Patient Treatment Preference Scale Question 1 | Have you used pharmaceutical treatments for your Parkinson's disease before the study? | 28 days |
| Patient Treatment Preference Scale Question 2 | Why did you decide to enter this study? | 28 days |
| Patient Treatment Preference Scale Question 3 | In comparing the patch and previous oral treatments for Parkinson's disease, how satisfied have you been with oral medication / patch? | 28 days |
| Patient Treatment Preference Scale Question 4 | I would prefer using a patch over taking a pill or capsule for treatment of my Parkinson's disease. | 28 days |
| Patient Treatment Preference Scale Question 5 | I would prefer applying one 40cm**2 patch over applying two 20cm**2 patches for treatment of my Parkinson's disease. | 28 days |
| Patient Treatment Preference Scale Question 6 | What aspects do you like the most about the patch? | 28 days |
| Patient Treatment Preference Scale Question 7 | What aspects do you like the least about the patch? Check all that apply. | 28 days |
| Lost to Follow-up |
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| Run-In Failure |
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| Screen Failure |
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| 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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| Primary | Change in Systolic Blood Pressure (Supine, After 1 Minute) | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mmHg | Baseline, 28 days |
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| Primary | Change in Diastolic Blood Pressure (Supine, After 1 Minute) | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mmHg | Baseline, 28 days |
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| Primary | Change in Pulse Rate (Supine, After 5 Minutes) | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | beats per minute | Baseline, 28 days |
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| Primary | Change in Systolic Blood Pressure (Supine, After 5 Minutes) | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mmHg | Baseline, 28 Days |
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| Primary | Change in Diastolic Blood Pressure (Supine, After 5 Minutes) | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mmHg | Baseline, 28 days |
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| Primary | Change in Pulse Rate (Standing, After 1 Minute) | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | beats per minute | Baseline, 28 days |
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| Primary | Change in Systolic Blood Pressure (Standing, After 1 Minute) | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mmHg | Baseline, 28 days |
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| Primary | Change in Diastolic Blood Pressure (Standing, After 1 Minute) | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mmHg | Baseline, 28 days |
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| Primary | Change in Pulse Rate (Standing, After 3 Minutes) | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | beats per minute | Baseline, 28 days |
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| Primary | Change in Systolic Blood Pressure (Standing, After 3 Minutes) | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mmHg | Baseline, 28 days |
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| Primary | Change in Diastolic Blood Pressure (Standing, After 3 Minutes) | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mmHg | Baseline, 28 days |
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| Primary | Change in Heart Rate | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | beats per minute | Baseline, 28 days |
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| Primary | Change in PR Interval | The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization (beginning of the QRS complex). Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | msec | Baseline, 28 days |
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| Primary | Change in QRS Duration | The QRS duration represents the time it takes for ventricular depolarization to occur. Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | msec | Baseline, 28 days |
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| Primary | Change in QT Interval | The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | msec | Baseline, 28 days |
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| Primary | Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) | The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | msec | Baseline, 28 days |
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| Primary | Change in Percentage of Basophilic Granulocytes in White Blood Cell Count | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | Percentage of white blood cell count | Baseline, 28 days |
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| Primary | Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | Percentage of white blood cell count | Baseline, 28 days |
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| Primary | Change in Hematocrit | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | l/l*100 | Baseline, 28 days |
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| Primary | Change in Hemoglobin | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | g/l | Baseline, 28 days |
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| Primary | Change in Percentage of Lymphocytes in White Blood Cell Count | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | Percentage of white blood cell count | Baseline, 28 days |
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| Primary | Change in Percentage of Monocytes in White Blood Cell Count | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | Percentage of white blood cell count | Baseline, 28 days |
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| Primary | Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | Percentage of white blood cell count | Baseline, 28 days |
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| Primary | Change in Platelet Count | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | Giga/l | Baseline, 28 days |
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| Primary | Change in Red Blood Cell Count | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | Tera/l | Baseline, 28 days |
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| Primary | Change in White Blood Cell Count | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | Giga/l | Baseline, 28 days |
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| Primary | Change in Albumin | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | g/l | Baseline, 28 days |
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| Primary | Change in Alkaline Phosphatase | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | Units/l | Baseline, 28 days |
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| Primary | Change in Blood Urea Nitrogen | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mmol/l | Baseline, 28 days |
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| Primary | Change in Calcium | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mg/dl | Baseline, 28 days |
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| Primary | Change in Chloride | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mmol/l | Baseline, 28 days |
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| Primary | Change in Creatinine | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mg/dl | Baseline, 28 days |
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| Primary | Change in Gamma-Glutamyltransferase | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | Units/l | Baseline, 28 days |
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| Primary | Change in Glucose | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mg/dl | Baseline, 28 days |
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| Primary | Change in Inorganic Phosphate | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mg/dl | Baseline, 28 days |
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| Primary | Change in Potassium | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mmol/l | Baseline, 28 days |
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| Primary | Change in Serum Glutamic Oxaloacetic Transaminase | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | Units/l | Baseline, 28 days |
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| Primary | Change in Glutamic Pyruvic Transaminase | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | Units/l | Baseline, 28 days |
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| Primary | Change in Sodium | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mmol/l | Baseline, 28 days |
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| Primary | Change in Total Bilirubin | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | mg/dl | Baseline, 28 days |
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| Primary | Change in Total Protein | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | g/dl | Baseline, 28 days |
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| Primary | Change in Uric Acid | Change = 28 day value minus baseline value. | Safety Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | µmol/l | Baseline, 28 days |
|
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|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
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| Primary | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
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| Primary | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
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|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other' | Safety Set, only patients with non-missing values were analyzed | Number | participants | 28 days |
|
|
|
| Primary | Completion of Trial From Baseline to End of Treatment | Safety Set | Number | participants | Baseline, 28 days |
|
|
|
| Primary | Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment | Safety Set | Number | participants | Baseline, 28 days |
|
|
|
| Primary | Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs) | Safety Set | Number | participants | Baseline, 2 days |
|
|
|
| Primary | Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period | Safety Set | Number | participants | Baseline, 56 days |
|
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|
| Primary | Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs) | Safety Set | Number | participants | Baseline, 2 days |
|
|
|
| Primary | Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period | Safety Set | Number | participants | Baseline, 56 days |
|
|
|
| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment | The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part I measures 'Mentation, Behavior and Mood'. Range: 0 (Best score possible) to 16 (Worst score possible) Change = 28 day value minus baseline value. | Full Analysis Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | score on scale | Baseline, 28 days |
|
|
|
| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment | The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part II measures 'Activities in Daily Living'. Range: 0 (Best score possible) to 52 (Worst score possible) Change = 28 day value minus baseline value. | Full Analysis Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | score on scale | Baseline, 28 days |
|
|
|
| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment | The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part III measures 'Motor Examination'. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 28 day value minus baseline value. | Full Analysis Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | score on scale | Baseline, 28 days |
|
|
|
| Secondary | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment | The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part IV measures 'Complications of Therapy'. Range: 0 (Best score possible) to 23 (Worst score possible) Change = 28 day value minus baseline value. | Full Analysis Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | score on scale | Baseline, 28 days |
|
|
|
| Secondary | Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment | The PDSS is a scale to assess sleep and nocturnal disability in Parkinson's disease. Range: 0 (Best score possible) to 60 (Worst score possible) Change = 28 day value minus baseline value. | Full Analysis Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | score on scale | Baseline, 28 days |
|
|
|
| Secondary | Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment | The ESS is a self-administered questionnaire in which the subject rates the probability of his/her dozing during 8 situations that are differently conductive to sleep Range: 0 (Best score possible) to 24 (Worst score possible) Change = 28 day value minus baseline value. | Full Analysis Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | score on scale | Baseline, 28 days |
|
|
|
| Secondary | Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment | The PDNMS is a rating by the clinician to assess the severity and frequency of non-motor symptoms in Parkinson's disease patients Range: 0 (Best score possible) to 384 (Worst score possible) Change = 28 day value minus baseline value. | Full Analysis Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | score on scale | Baseline, 28 days |
|
|
|
| Secondary | Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment | The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 1 measures 'Severity of Parkinson's Disease'. Range: 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients) Change = 28 day value minus baseline value. | Full Analysis Set | Mean | Standard Deviation | score on scale | Baseline, 28 days |
|
|
|
| Secondary | Clinical Global Impression (CGI) Item 2 Score | The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 2 measures 'Global Improvement'. Range 1 (Very much improved) to 7 (Very much worse) | Full Analysis Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | score on scale | 28 days |
|
|
|
| Secondary | Clinical Global Impression (CGI) Item 3.1 | The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 3.1 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms.) to 4 (Unchanged or worse) | Full Analysis Set | Number | participants | 28 days |
|
|
|
| Secondary | Clinical Global Impression (CGI) Item 3.2 | The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 3.2 measures 'Therapeutic Side Effects'. Range: 1 (None) to 4 (Outweigh the therapeutic effect) | Full Analysis Set | Number | participants | 28 days |
|
|
|
| Secondary | Patient Global Impression (PGI) Item 1 Score | The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 1 measures 'Global Improvement'. Range: 1 (Very much improved) to 7 (Very much worse) | Full Analysis Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | score on scale | 28 days |
|
|
|
| Secondary | Patient Global Impression (PGI) Item 2 | The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 2 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms) to 4 (Unchanged or worse) | Full Analysis Set | Number | participants | 28 days |
|
|
|
| Secondary | Patient Global Impression (PGI) Item 3 | The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time. Item 3 measures 'Side Effects'. Range: 1 (I have no side effects) to 4 (They outweigh the therapeutic effect of the trial medication) | Full Analysis Set | Number | participants | 28 days |
|
|
|
| Secondary | Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment | The PDQ-8 is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease. Range: 0 (good health) to 100 (poor health) Change = 28 day value minus baseline value. | Full Analysis Set, only patients with non-missing values were analyzed | Mean | Standard Deviation | score on scale | Baseline, 28 days |
|
|
|
| Secondary | Patient Treatment Preference Scale Question 1 | Have you used pharmaceutical treatments for your Parkinson's disease before the study? | Full Analysis Set | Number | participants | 28 days |
|
|
|
| Secondary | Patient Treatment Preference Scale Question 2 | Why did you decide to enter this study? | Full Analysis Set | Number | participants | 28 days |
|
|
|
| Secondary | Patient Treatment Preference Scale Question 3 | In comparing the patch and previous oral treatments for Parkinson's disease, how satisfied have you been with oral medication / patch? | Full Analysis Set | Number | participants | 28 days |
|
|
|
| Secondary | Patient Treatment Preference Scale Question 4 | I would prefer using a patch over taking a pill or capsule for treatment of my Parkinson's disease. | Full Analysis Set | Number | participants | 28 days |
|
|
|
| Secondary | Patient Treatment Preference Scale Question 5 | I would prefer applying one 40cm**2 patch over applying two 20cm**2 patches for treatment of my Parkinson's disease. | Full Analysis Set | Number | participants | 28 days |
|
|
|
| Secondary | Patient Treatment Preference Scale Question 6 | What aspects do you like the most about the patch? | Full Analysis Set | Number | participants | 28 days |
|
|
|
| Secondary | Patient Treatment Preference Scale Question 7 | What aspects do you like the least about the patch? Check all that apply. | Full Analysis Set | Number | participants | 28 days |
|
|
|
| 0 |
| 116 |
| 45 |
| 116 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Gait disturbence | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Bradykinesia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Rapid eye movements sleep abnormal | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Libido increased | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | 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 |
| Title | Measurements |
|---|
|
| Unchanged or Worse |
|
| Not Assessed |
|
| Title | Measurements |
|---|---|
|
| Outweigh the Theraputic Effect |
|
| Not Assessed |
|
| Title | Measurements |
|---|
|
| Unchanged or Worse |
|
| Missing / Not Done |
|
| Title | Measurements |
|---|---|
|
| Outweighing Therapeutic Effect of Trial Medication |
|
| Missing / Not Done |
|
|
| Other |
|
| Title | Measurements |
|---|
|
| Satisfied with Oral Medication |
|
| Very Satisfied with Oral Medication |
|
| Assessment for Oral Medication Missing / Not Done |
|
| Very Dissatisfied with Patch |
|
| Dissatisfied with Patch |
|
| Neither Satisfied nor Dissatisfied with Patch |
|
| Satisfied with Patch |
|
| Very Satisfied with Patch |
|
| Assessment for Patch Missing / Not Done |
|
| Measurements |
|---|
|
| Disagree |
|
| Strongly Disagree |
|
| Not Done / Missing |
|
| Measurements |
|---|
|
| Disagree |
|
| Strongly Disagree |
|
| Not Done / Missing |
|
|
| Do not have to take medicine in public |
|
| Provides symptom relief all day |
|
| Convenient |
|
| Easy to apply |
|
| Do not have to remember to take med. during day |
|
| Missing / Not Done |
|
|
| Did not stay on for the entire day |
|
| Uncomfortable to wear |
|
| Not always covered by clothing |
|
| Symptom relief did not last all day |
|
| Not Done / Missing |
|