Parkinson's Disease
Conditions
Keywords
Rotigotine, NEUPRO, Switching trial from ropinirole to rotigotine,, safety and tolerability, Parkinson disease
Brief summary
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
Interventions
DRUGRotigotine
Strength: 2,4,6,and 8mg/24h, form: transdermal application, once daily application
Sponsors
UCB Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject is informed and given ample time and opportunity to think about his/her participation in this trial and has given his/her written informed consent. * Subject is willing and able to comply with all trial requirements. * Subject is male or female, aged≥ 18 years. * Subject is Korean. * Subjects with idiopathic Parkinson's disease (Hoehn and Yahr Stage I-IV) as defined by the cardinal sign, bradykinesia, and at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes. * Subject is not satisfactorily controlled on a total daily dose of ropinirole from 3mg to 12mg, inclusive. * If the subject is receiving levodopa, either short-acting or sustained-release (in combination with benserazide or carbidopa), the total daily dose must be stable for 28 days prior to the Baseline Visit and must remain stable for the Treatment Period. * If the subject is receiving an anticholinergic agent (eg, benztropine, trihexyphenidyl, parsitan, procyclidine, biperiden), a monoamine oxidase B (MAO-B) inhibitor (eg, selegiline), a COMT inhibitor (eg, entacapone), or an N-methyl-d-aspartate (NMDA)-antagonist (eg, amantadine), he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit and must be maintained on that dose for the Treatment Period
Exclusion criteria
Subjects are not permitted to enroll in the trial if any of the following criteria are met: * Subject has previously participated in a trial with rotigotine. * Subject has participated in another trial of an investigational drug within 28 days prior to the Baseline Visit or is currently participating in another trial of an investigational drug. * Subject has atypical Parkinsonian syndrome(s), including drug-induced Parkinsonian syndrome(s). * Subject has dementia, active psychosis, or hallucinations (not due to antiparkinsonian medication). * Subject is receiving therapy with 1 of the following drugs either concurrently or within 28 days prior to Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine. * Subject is currently receiving central nervous system (CNS) active therapy (eg, sedatives, hypnotics, antidepressants, anxiolytics), unless the dose has been stable for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the trial. * Subject has a history of seizures or stroke within 1 year, has had a Transient Ischemic Attack (TIA) within 12 months prior to enrollment, or a history of myocardial infarction within the last 6 months prior to enrollment. * Presence of clinically relevant hepatic dysfunction. * Presence of clinically relevant renal dysfunction. * Evidence of clinically relevant cardiovascular disorders. * Subject has a QTcB interval of ≥ 500ms at Pretreatment or Baseline (repeated measurements within 1 hour). * Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to Baseline. * Subject has a history of significant skin hypersensitivity to adhesive or other transdermals or recent unresolved contact dermatitis. * Subject has malignant neoplastic disease requiring therapy within 12 months prior to enrollment. * Subject has a history of chronic alcohol or drug abuse within the last 6 months. * Subject has taken herbal medicine therapy within the last 2 weeks prior to the Baseline Visit. * Subject has clinically significant laboratory results that, in the judgment of the investigator, would make the subject unsuitable for entry into the trial. * Subject is pregnant or nursing, or is of childbearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods (including at least 1 barrier method), or (iii) not sexually abstinent or (iv) not at least 2 years postmenopausal. * Subject has evidence of an impulse control disorder according to the Jay Modified Minnesota Impulsive Disorders Interview (mMIDI) at Pretreatment (Visit 1). * Subject has any other clinically significant medical or psychiatric condition that would, in the judgment of the investigator, interfere with the subject's ability to participate in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period | Baseline, 56 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 | — |
| Change in Systolic Blood Pressure (Supine, After 5 Minutes) | Baseline, 28 Days | Change = 28 day value minus baseline value. |
| Change in Diastolic Blood Pressure (Supine, After 5 Minutes) | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Pulse Rate (Standing, After 1 Minute) | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Systolic Blood Pressure (Standing, After 1 Minute) | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in White Blood Cell Count | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Albumin | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Alkaline Phosphatase | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Blood Urea Nitrogen | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Calcium | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Chloride | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Percentage of Monocytes in White Blood Cell Count | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Pulse Rate (Supine, After 1 Minute) | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Systolic Blood Pressure (Supine, After 1 Minute) | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Diastolic Blood Pressure (Supine, After 1 Minute) | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Pulse Rate (Supine, After 5 Minutes) | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Diastolic Blood Pressure (Standing, After 1 Minute) | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Platelet Count | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Pulse Rate (Standing, After 3 Minutes) | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Systolic Blood Pressure (Standing, After 3 Minutes) | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Diastolic Blood Pressure (Standing, After 3 Minutes) | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Heart Rate | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in PR Interval | Baseline, 28 days | 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. |
| Change in QRS Duration | Baseline, 28 days | The QRS duration represents the time it takes for ventricular depolarization to occur. Change = 28 day value minus baseline value. |
| Change in QT Interval | Baseline, 28 days | 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. |
| Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) | Baseline, 28 days | 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. |
| Change in Percentage of Basophilic Granulocytes in White Blood Cell Count | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Hematocrit | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Hemoglobin | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Red Blood Cell Count | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Percentage of Lymphocytes in White Blood Cell Count | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Creatinine | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Gamma-Glutamyltransferase | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Glucose | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Inorganic Phosphate | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Potassium | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Serum Glutamic Oxaloacetic Transaminase | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Glutamic Pyruvic Transaminase | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Sodium | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Total Bilirubin | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Total Protein | Baseline, 28 days | Change = 28 day value minus baseline value. |
| Change in Uric Acid | Baseline, 28 days | Change = 28 day value minus baseline value. |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment | Baseline, 28 days | 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. |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment | Baseline, 28 days | 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. |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment | Baseline, 28 days | 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. |
| Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment | Baseline, 28 days | 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. |
| Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment | Baseline, 28 days | 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. |
| Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment | Baseline, 28 days | 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. |
| Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment | Baseline, 28 days | 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. |
| Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment | Baseline, 28 days | 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. |
| Clinical Global Impression (CGI) Item 2 Score | 28 days | 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) |
| Clinical Global Impression (CGI) Item 3.1 | 28 days | 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) |
| Clinical Global Impression (CGI) Item 3.2 | 28 days | 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) |
| Patient Global Impression (PGI) Item 1 Score | 28 days | 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) |
| Patient Global Impression (PGI) Item 2 | 28 days | 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) |
| Patient Global Impression (PGI) Item 3 | 28 days | 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) |
| Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment | Baseline, 28 days | 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. |
| Patient Treatment Preference Scale Question 1 | 28 days | Have you used pharmaceutical treatments for your Parkinson's disease before the study? |
| Patient Treatment Preference Scale Question 2 | 28 days | Why did you decide to enter this study? |
| Patient Treatment Preference Scale Question 3 | 28 days | In comparing the patch and previous oral treatments for Parkinson's disease, how satisfied have you been with oral medication / patch? |
| Patient Treatment Preference Scale Question 4 | 28 days | I would prefer using a patch over taking a pill or capsule for treatment of my Parkinson's disease. |
| Patient Treatment Preference Scale Question 6 | 28 days | What aspects do you like the most about the patch? |
| Patient Treatment Preference Scale Question 7 | 28 days | What aspects do you like the least about the patch? Check all that apply. |
| Patient Treatment Preference Scale Question 5 | 28 days | I would prefer applying one 40cm\*\*2 patch over applying two 20cm\*\*2 patches for treatment of my Parkinson's disease. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 116 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 13 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Run-In Failure | 5 |
| Overall Study | Screen Failure | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Rotigotine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 43 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants |
| Age, Continuous | 60.0 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment Korea, Republic of | 116 participants |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 45 / 116 |
| serious Total, serious adverse events | 0 / 116 |
Outcome results
Primary
Change in Albumin
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Albumin | -0.5 g/l | Standard Deviation 2.1 |
Primary
Change in Alkaline Phosphatase
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Alkaline Phosphatase | -1.4 Units/l | Standard Deviation 16.9 |
Primary
Change in Blood Urea Nitrogen
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Blood Urea Nitrogen | -0.24 mmol/l | Standard Deviation 1.75 |
Primary
Change in Calcium
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Calcium | -0.05 mg/dl | Standard Deviation 0.3 |
Primary
Change in Chloride
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Chloride | -0.4 mmol/l | Standard Deviation 2.5 |
Primary
Change in Creatinine
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Creatinine | -0.004 mg/dl | Standard Deviation 0.101 |
Primary
Change in Diastolic Blood Pressure (Standing, After 1 Minute)
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Diastolic Blood Pressure (Standing, After 1 Minute) | 0.8 mmHg | Standard Deviation 10.1 |
Primary
Change in Diastolic Blood Pressure (Standing, After 3 Minutes)
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Diastolic Blood Pressure (Standing, After 3 Minutes) | 0.8 mmHg | Standard Deviation 9.1 |
Primary
Change in Diastolic Blood Pressure (Supine, After 1 Minute)
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Diastolic Blood Pressure (Supine, After 1 Minute) | 1.7 mmHg | Standard Deviation 9.6 |
Primary
Change in Diastolic Blood Pressure (Supine, After 5 Minutes)
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Diastolic Blood Pressure (Supine, After 5 Minutes) | 0.6 mmHg | Standard Deviation 9.8 |
Primary
Change in Gamma-Glutamyltransferase
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Gamma-Glutamyltransferase | -0.1 Units/l | Standard Deviation 7.5 |
Primary
Change in Glucose
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Glucose | -0.2 mg/dl | Standard Deviation 30 |
Primary
Change in Glutamic Pyruvic Transaminase
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Glutamic Pyruvic Transaminase | -0.2 Units/l | Standard Deviation 15.6 |
Primary
Change in Heart Rate
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Heart Rate | 0.5 beats per minute | Standard Deviation 8.7 |
Primary
Change in Hematocrit
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Hematocrit | 0.09 l/l*100 | Standard Deviation 1.71 |
Primary
Change in Hemoglobin
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Hemoglobin | 0.8 g/l | Standard Deviation 5.6 |
Primary
Change in Inorganic Phosphate
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Inorganic Phosphate | -0.03 mg/dl | Standard Deviation 0.52 |
Primary
Change in Percentage of Basophilic Granulocytes in White Blood Cell Count
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Percentage of Basophilic Granulocytes in White Blood Cell Count | 0.01 Percentage of white blood cell count | Standard Deviation 0.33 |
Primary
Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count | -0.11 Percentage of white blood cell count | Standard Deviation 1.71 |
Primary
Change in Percentage of Lymphocytes in White Blood Cell Count
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Percentage of Lymphocytes in White Blood Cell Count | 0.73 Percentage of white blood cell count | Standard Deviation 7.12 |
Primary
Change in Percentage of Monocytes in White Blood Cell Count
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Percentage of Monocytes in White Blood Cell Count | 0.96 Percentage of white blood cell count | Standard Deviation 8.41 |
Primary
Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count | -0.40 Percentage of white blood cell count | Standard Deviation 12.69 |
Primary
Change in Platelet Count
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Platelet Count | 2.6 Giga/l | Standard Deviation 29.5 |
Primary
Change in Potassium
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Potassium | 0.08 mmol/l | Standard Deviation 0.35 |
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.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in PR Interval | -0.0 msec | Standard Deviation 14.6 |
Primary
Change in Pulse Rate (Standing, After 1 Minute)
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Pulse Rate (Standing, After 1 Minute) | 1.7 beats per minute | Standard Deviation 11.8 |
Primary
Change in Pulse Rate (Standing, After 3 Minutes)
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Pulse Rate (Standing, After 3 Minutes) | 0.8 beats per minute | Standard Deviation 11.1 |
Primary
Change in Pulse Rate (Supine, After 1 Minute)
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Pulse Rate (Supine, After 1 Minute) | 2.0 beats per minute | Standard Deviation 9.4 |
Primary
Change in Pulse Rate (Supine, After 5 Minutes)
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Pulse Rate (Supine, After 5 Minutes) | 1.8 beats per minute | Standard Deviation 8.8 |
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.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in QRS Duration | -1.2 msec | Standard Deviation 6.3 |
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.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in QT Interval | -1.7 msec | Standard Deviation 30.5 |
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.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) | 0.5 msec | Standard Deviation 23.1 |
Primary
Change in Red Blood Cell Count
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Red Blood Cell Count | 0.023 Tera/l | Standard Deviation 0.213 |
Primary
Change in Serum Glutamic Oxaloacetic Transaminase
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Serum Glutamic Oxaloacetic Transaminase | -0.1 Units/l | Standard Deviation 7.9 |
Primary
Change in Sodium
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Sodium | -0.6 mmol/l | Standard Deviation 2.2 |
Primary
Change in Systolic Blood Pressure (Standing, After 1 Minute)
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Systolic Blood Pressure (Standing, After 1 Minute) | -0.2 mmHg | Standard Deviation 12.7 |
Primary
Change in Systolic Blood Pressure (Standing, After 3 Minutes)
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Systolic Blood Pressure (Standing, After 3 Minutes) | 2.0 mmHg | Standard Deviation 12.4 |
Primary
Change in Systolic Blood Pressure (Supine, After 1 Minute)
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Systolic Blood Pressure (Supine, After 1 Minute) | 5.7 mmHg | Standard Deviation 14.1 |
Primary
Change in Systolic Blood Pressure (Supine, After 5 Minutes)
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 Days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Systolic Blood Pressure (Supine, After 5 Minutes) | 2.6 mmHg | Standard Deviation 13.1 |
Primary
Change in Total Bilirubin
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Total Bilirubin | 0.079 mg/dl | Standard Deviation 1.133 |
Primary
Change in Total Protein
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Total Protein | -0.09 g/dl | Standard Deviation 0.36 |
Primary
Change in Uric Acid
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Uric Acid | -3.80 µmol/l | Standard Deviation 35.62 |
Primary
Change in White Blood Cell Count
Change = 28 day value minus baseline value.
Time frame: Baseline, 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in White Blood Cell Count | -0.045 Giga/l | Standard Deviation 3.538 |
Primary
Completion of Trial From Baseline to End of Treatment
Time frame: Baseline, 28 days
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Completion of Trial From Baseline to End of Treatment | 99 participants |
Primary
Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment
Time frame: Baseline, 28 days
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment | 88 participants |
Primary
Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
Time frame: Baseline, 56 days
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period | 1 participants |
Primary
Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
Time frame: Baseline, 2 days
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs) | 1 participants |
Primary
Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
Time frame: Baseline, 56 days
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period | 9 participants |
Primary
Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
Time frame: Baseline, 2 days
Population: Safety Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs) | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait' | 1 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements' | 1 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological' | 1 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal' | 1 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary' | 0 participants |
Primary
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'
Time frame: 28 days
Population: Safety Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rotigotine | Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological' | 0 participants |
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.
Time frame: Baseline, 28 days
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment | -0.0 score on scale | Standard Deviation 0.6 |
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.
Time frame: Baseline, 28 days
Population: Full Analysis Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment | -0.2 score on scale | Standard Deviation 3.2 |
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.
Time frame: Baseline, 28 days
Population: Full Analysis Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment | -7.9 score on scale | Standard Deviation 19.8 |
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.
Time frame: Baseline, 28 days
Population: Full Analysis Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment | -0.8 score on scale | Standard Deviation 7.3 |
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.
Time frame: Baseline, 28 days
Population: Full Analysis Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment | -3.9 score on scale | Standard Deviation 13.5 |
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.
Time frame: Baseline, 28 days
Population: Full Analysis Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment | -1.9 score on scale | Standard Deviation 5.9 |
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.
Time frame: Baseline, 28 days
Population: Full Analysis Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment | -0.9 score on scale | Standard Deviation 3.3 |
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.
Time frame: Baseline, 28 days
Population: Full Analysis Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment | -0.5 score on scale | Standard Deviation 1.2 |
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.
Time frame: Baseline, 28 days
Population: Full Analysis Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment | -0.4 score on scale | Standard Deviation 1.8 |
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)
Time frame: 28 days
Population: Full Analysis Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Clinical Global Impression (CGI) Item 2 Score | 3.6 score on scale | Standard Deviation 1 |
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)
Time frame: 28 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine | Clinical Global Impression (CGI) Item 3.1 | Marked | 3 participants |
| Rotigotine | Clinical Global Impression (CGI) Item 3.1 | Moderate | 20 participants |
| Rotigotine | Clinical Global Impression (CGI) Item 3.1 | Minimal | 36 participants |
| Rotigotine | Clinical Global Impression (CGI) Item 3.1 | Unchanged or Worse | 54 participants |
| Rotigotine | Clinical Global Impression (CGI) Item 3.1 | Not Assessed | 1 participants |
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)
Time frame: 28 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine | Clinical Global Impression (CGI) Item 3.2 | None | 88 participants |
| Rotigotine | Clinical Global Impression (CGI) Item 3.2 | No Significant Interference with Subj. Functioning | 18 participants |
| Rotigotine | Clinical Global Impression (CGI) Item 3.2 | Significant Interference with Subj. Functioning | 5 participants |
| Rotigotine | Clinical Global Impression (CGI) Item 3.2 | Outweigh the Theraputic Effect | 2 participants |
| Rotigotine | Clinical Global Impression (CGI) Item 3.2 | Not Assessed | 1 participants |
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)
Time frame: 28 days
Population: Full Analysis Set, only patients with non-missing values were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine | Patient Global Impression (PGI) Item 1 Score | 3.6 score on scale | Standard Deviation 1.2 |
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)
Time frame: 28 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine | Patient Global Impression (PGI) Item 2 | Marked | 5 participants |
| Rotigotine | Patient Global Impression (PGI) Item 2 | Moderate | 25 participants |
| Rotigotine | Patient Global Impression (PGI) Item 2 | Minimal | 38 participants |
| Rotigotine | Patient Global Impression (PGI) Item 2 | Unchanged or Worse | 44 participants |
| Rotigotine | Patient Global Impression (PGI) Item 2 | Missing / Not Done | 2 participants |
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)
Time frame: 28 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine | Patient Global Impression (PGI) Item 3 | No Side Effects | 77 participants |
| Rotigotine | Patient Global Impression (PGI) Item 3 | No Significant Interference with Functioning | 24 participants |
| Rotigotine | Patient Global Impression (PGI) Item 3 | Significant Interference with Functioning | 6 participants |
| Rotigotine | Patient Global Impression (PGI) Item 3 | Outweighing Therapeutic Effect of Trial Medication | 5 participants |
| Rotigotine | Patient Global Impression (PGI) Item 3 | Missing / Not Done | 2 participants |
Secondary
Patient Treatment Preference Scale Question 1
Have you used pharmaceutical treatments for your Parkinson's disease before the study?
Time frame: 28 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine | Patient Treatment Preference Scale Question 1 | yes | 114 participants |
| Rotigotine | Patient Treatment Preference Scale Question 1 | no | 0 participants |
Secondary
Patient Treatment Preference Scale Question 2
Why did you decide to enter this study?
Time frame: 28 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine | Patient Treatment Preference Scale Question 2 | Side effects with oral medicine | 14 participants |
| Rotigotine | Patient Treatment Preference Scale Question 2 | Oral medicine not effective in controlling sympt. | 21 participants |
| Rotigotine | Patient Treatment Preference Scale Question 2 | Taking med. several times a day was not convenient | 71 participants |
| Rotigotine | Patient Treatment Preference Scale Question 2 | Other | 40 participants |
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?
Time frame: 28 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine | Patient Treatment Preference Scale Question 3 | Very Dissatisfied with Oral Medication | 3 participants |
| Rotigotine | Patient Treatment Preference Scale Question 3 | Dissatisfied with Oral Medication | 11 participants |
| Rotigotine | Patient Treatment Preference Scale Question 3 | Neither Satisfied nor Dissatisfied with Oral Med. | 49 participants |
| Rotigotine | Patient Treatment Preference Scale Question 3 | Satisfied with Oral Medication | 43 participants |
| Rotigotine | Patient Treatment Preference Scale Question 3 | Very Satisfied with Oral Medication | 6 participants |
| Rotigotine | Patient Treatment Preference Scale Question 3 | Assessment for Oral Medication Missing / Not Done | 2 participants |
| Rotigotine | Patient Treatment Preference Scale Question 3 | Very Dissatisfied with Patch | 9 participants |
| Rotigotine | Patient Treatment Preference Scale Question 3 | Dissatisfied with Patch | 28 participants |
| Rotigotine | Patient Treatment Preference Scale Question 3 | Neither Satisfied nor Dissatisfied with Patch | 34 participants |
| Rotigotine | Patient Treatment Preference Scale Question 3 | Satisfied with Patch | 32 participants |
| Rotigotine | Patient Treatment Preference Scale Question 3 | Very Satisfied with Patch | 9 participants |
| Rotigotine | Patient Treatment Preference Scale Question 3 | Assessment for Patch Missing / Not Done | 2 participants |
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.
Time frame: 28 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine | Patient Treatment Preference Scale Question 4 | Strongly Agree | 18 participants |
| Rotigotine | Patient Treatment Preference Scale Question 4 | Agree | 34 participants |
| Rotigotine | Patient Treatment Preference Scale Question 4 | Neither Agree nor Disagree | 29 participants |
| Rotigotine | Patient Treatment Preference Scale Question 4 | Disagree | 28 participants |
| Rotigotine | Patient Treatment Preference Scale Question 4 | Strongly Disagree | 3 participants |
| Rotigotine | Patient Treatment Preference Scale Question 4 | Not Done / Missing | 2 participants |
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.
Time frame: 28 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine | Patient Treatment Preference Scale Question 5 | Strongly Agree | 17 participants |
| Rotigotine | Patient Treatment Preference Scale Question 5 | Agree | 68 participants |
| Rotigotine | Patient Treatment Preference Scale Question 5 | Neither Agree nor Disagree | 10 participants |
| Rotigotine | Patient Treatment Preference Scale Question 5 | Disagree | 13 participants |
| Rotigotine | Patient Treatment Preference Scale Question 5 | Strongly Disagree | 4 participants |
| Rotigotine | Patient Treatment Preference Scale Question 5 | Not Done / Missing | 2 participants |
Secondary
Patient Treatment Preference Scale Question 6
What aspects do you like the most about the patch?
Time frame: 28 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine | Patient Treatment Preference Scale Question 6 | Applying the patch once a day | 81 participants |
| Rotigotine | Patient Treatment Preference Scale Question 6 | Comfortable to wear | 28 participants |
| Rotigotine | Patient Treatment Preference Scale Question 6 | Does not interfere with my normal activities | 61 participants |
| Rotigotine | Patient Treatment Preference Scale Question 6 | Do not have to take medicine in public | 56 participants |
| Rotigotine | Patient Treatment Preference Scale Question 6 | Provides symptom relief all day | 46 participants |
| Rotigotine | Patient Treatment Preference Scale Question 6 | Convenient | 53 participants |
| Rotigotine | Patient Treatment Preference Scale Question 6 | Easy to apply | 50 participants |
| Rotigotine | Patient Treatment Preference Scale Question 6 | Do not have to remember to take med. during day | 60 participants |
| Rotigotine | Patient Treatment Preference Scale Question 6 | Missing / Not Done | 2 participants |
Secondary
Patient Treatment Preference Scale Question 7
What aspects do you like the least about the patch? Check all that apply.
Time frame: 28 days
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine | Patient Treatment Preference Scale Question 7 | Hard to apply | 11 participants |
| Rotigotine | Patient Treatment Preference Scale Question 7 | Hard to remove | 3 participants |
| Rotigotine | Patient Treatment Preference Scale Question 7 | Hard to remove the patch from its pouch | 1 participants |
| Rotigotine | Patient Treatment Preference Scale Question 7 | Did not stay on for the entire day | 80 participants |
| Rotigotine | Patient Treatment Preference Scale Question 7 | Uncomfortable to wear | 27 participants |
| Rotigotine | Patient Treatment Preference Scale Question 7 | Not always covered by clothing | 8 participants |
| Rotigotine | Patient Treatment Preference Scale Question 7 | Symptom relief did not last all day | 29 participants |
| Rotigotine | Patient Treatment Preference Scale Question 7 | Not Done / Missing | 2 participants |